Osteoarthritis, KneePhase 1/2NCT06105840
Combination of Curcuminoid With Acupressure for Inflammation and Pain in the Elderly With Osteoarthritis Genu
A Phase 1/2 study testing Acupressure and Standardized Curcuminoid from Turmeric Extract in people with Osteoarthritis, Knee, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to to investigate the efficacy of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers, endorphin hormones in the blood and quality of life in elderly patient with Osteoarthritis Genu. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Acupressure and Standardized Curcuminoid from Turmeric Extract
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Aug 2023to 31 Oct 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The inclusion criteria in this study are:
- Clinical diagnosis of osteoarthritis which confirmed by physical examination and x-rays
- Experience pain with a Numeric Rating scale of 1-7
- Must be able to swallow capsules
- Must be able to carry out mobility without assistance or with minimal assistance
The exclusion criteria in this study are:
- Parkinson's disease
- Dementia disease
- Psychosis disease
- New bone fractures
- Joint dislocations
- Cancer
- Rheumatic diseases other than osteoarthritis (rheumatoid arthritis)
- Undergoing joint replacement therapy.
- Analgesic dependent disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Padukuhan Tanjungsari Kelurahan Sukoharjo Ngaglik
Sleman, Special Region of Yogyakarta
About this study
Official title: Effect of Combination of Curcuminoid Standardized Turmeric Extract With Acupressure on Inflammatory Markers, Endorphins and Quality of Life in Elderly People With Osteoarthritis Genu
The goal of this clinical trial is to to investigate the efficacy of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers, endorphin hormones in the blood and quality of life in elderly patient with Osteoarthritis Genu.
The main questions it aims to answer are:
Read more
- Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers in elderly patients with Osteoarthritis Genu?
- Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to endorphin hormones in the blood in elderly patients with Osteoarthritis Genu?
- Is there an effect combination of acupressure and standardized curcuminoids from turmeric extract to quality of life in elderly patients with Osteoarthritis Genu?
Participants in the intervention group received 2 treatments, namely acupressure at points that provide osteoarthritis-specific comfort and standardized curcuminoids from turmeric extract capsules. Participant in the control group alo would receive 2 treatments, an active placebo (starch capsules and sham acupressure).
Researchers will compare interventional group and sham group to see efficacy the combination therapy
Read the detailed description
Background. One of the degeneration processes that occurs in the elderly is the musculoskeletal system. These deteriorations include bone loss and a decrease in joint fluid volume which is exacerbated by bearing the weight of the body. Pain in Osteoarthritis patients affects many areas of quality of life such as physical function, emotional behavior, and mental health. Osteoarthritis-related pain is a major factor in poor quality of life. The most common pharmacological treatment to control pain is the use of non-steroidal anti-inflammatory drugs (NSAIDs), but these drugs carry the risk of causing side effects. Limitations associated with pharmacologic treatment result in patients choosing commonly available alternative therapies for pain management. Popular alternative therapies include herbal therapy, therapeutic touch, relaxation techniques, music therapy, acupuncture, and acupressure. This alternative therapy, unlike the use of drugs, does not produce dangerous side effects.
Research on the effectiveness of herbal therapy on inflammatory osteoarthritis patients was conducted in Indonesia in 2009 on 80 sufferers with the result that administration of turmeric rhizome extract curcuminoids significantly suppressed the activity of synovial fluid monocytes to secrete Cyclooxygenase-2 (COX-2) and Reactive Oxygen Intermediate (ROI), reduced leukocyte numbers and fluid Malondialdehyde (MDA) levels. synovia and reduces Osteoarthritis (OA) joint pain, with an ability that is not significantly different compared to diclofenac sodium therapy 3x25 mg per day. Furthermore, the development of herbal therapy for Osteoathritis continued with research which proved that the combination of ginger, ginger, soybean and shrimp shell extracts provided significant results in reducing joint pain, stiffness and physical disability which were evaluated based on the Western Ontario and McMaster values. Universities Osteoarthritis Index (WOMAC) and did not show a significant difference when compared with meloxicam.
Research that has been carried out to evaluate the effectiveness of acupressure therapy for the pain of Osteoarthritis patients was also carried out in several countries, including by study on 40 Osteoarthritis patients who were divided into two groups (intervention and control). In the intervention group, acupressure therapy was given for 5 days with a duration of 30 minutes each time. The results showed that the average pain score in the intervention group decreased significantly from 5.89 at the beginning of the study to 4.11 at the end of the study, while the pain score did not change substantially in the control group. These findings remained consistent after adjusting for age, weight, and pretreatment covariates. This study supports the evidence that Acupressure therapy provides an effective option for short-term knee pain relief in patients with knee Osteoarthritis. In line with the results, there was research which was conducted on 51 elderly with osteoarthritis divided into 3 groups (acupressure intervention, placebo and control). This study revealed that respondents who received acupressure therapy for 3-4 weeks with the duration of each therapy being 10-15 minutes, showed a significant reduction in the total WOMAC index, pain and physical dysfunction.
So far, there has been no research combining standardized curcuminoid turmeric extract therapy with acupressure for inflammation and pain in osteoarthritis patients. More clinical trials with appropriate methodology are needed to confirm the effectiveness of standardized turmeric extract, curcuminoids and acupressure to treat physical problems in osteoarthritis patients.
Study Design/Methods. The research will be carried out by design Randomized Controlled Trials (RCT). Respondents will be divided randomly into 2 groups, namely treatment and control. The treatment group will receive interventions, namely herbal therapy and acupressure therapy, while the control group will receive active placebo (capsules containing starch and acupressure massage at points that are not to provide comfort for knee pain). In this study, a double blind technique was used , that is, the subjects and researchers did not know which respondents were in the treatment group and which respondents were in the control group.
Data Analysis Plan
- Analysis Descriptive Data obtained done tabulation in accordance with general data grouping and special data results measurement variable pre-test and post-test research . Data analysis will used For get description general from each variable . Data processing uses distribution frequency , reading data distribution (mean, mode, median, etc deviation )
- Analysis Inferential For know difference effectiveness on second group , researcher use Test the Difference with using the Independent T-Test and Wilcoxon Sign Rank Test. Analysis done on difference all over variable before And after done intervention on second group
- Conditions
- Osteoarthritis, Knee
- Being tested
- Acupressure and Standardized Curcuminoid from Turmeric Extract, Sham Acupressure and Placebo
- Keywords
- curcuminoid, acupressure, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure and Standardized Curcuminoid from Turmeric ExtractProcedure or surgery
capsules containing curcuminoid from Tumeric Extract three times a day for 3 weeks and acupressure massage at points provide comfort for knee pain twice a week for 3 weeks
Sham Acupressure and PlaceboProcedure or surgery
capsules containing starch three times a day for 3 weeks and acupressure massage at points that are not to provide comfort for knee pain twice a week for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Groups assigned randomly using lottery draw number 1 Receives: Procedure: Acupressure and Standardized Curcuminoid from Turmeric Extract |
| Control Group | Sham comparator | Groups assigned randomly using lottery draw number 2 Receives: Procedure: Sham Acupressure and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation Marker
Inflammation markers are carried out by measuring Leukocyte Number, NLR, Blood Sediment Rate and COX-2 hormone. Outcome measurements will be carried out a complete blood test using a Hematology Analyzer. Leukocyte numbers measured in microliter (mcL). Neutrophil-Lymphocyte Count Ratio can be calculated from the number of neutrophils (cells) and lymphocytes (cells). Neutrophils and lymphocytes will be combined to report Neutrophil-Lymphocyte Count Ratio in %. Blood Sediment Rate is a measurement of the difference in the decrease in height of red blood cells in a test tube (mm) divided by the time (hours) required for all of them to settle to the bottom of the test tube. There will be combined to report Blood Sediment Rate in mm/hr. The COX-2 hormone examination was carried out using the Enzyme Linked Immunosorbent Assay (ELISA). The amount of COX-2 Hormone in the blood in nanograms and blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL
Measured: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy
Endorphin Hormones
Secretion of endorphin hormones Endorphins, in this case beta endorphin, are hormones released by the pituitary gland in response to stress or pain, which are also secreted in blood plasma. Endorphin hormone examination is carried out using the Enzyme Linked Immunosorbent Assay (ELISA) method on blood plasma. The amount of Endorphin Hormone in the blood in nanograms and the blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL
Measured: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start27 Aug 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinalesti Mahanani, Gadjah Mada University
- Investigators
- Srinalesti Mahanani, Magister, Principal investigator, Faculty of Medicine University of Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105840
- Sponsor's protocol ID
- KE/FK/0674/EC/2023
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alinaghizadeh M, Hawkins J, Abbassian A, Seif Barghi T, Ayati MH, Alizadeh Vaghasloo M. Effect of Persian acupressure (Ghamz) on Patients with Knee Osteoarthritis: A Single-Blinded Parallel Clinical Trial. Pain Manag Nurs. 2021 Dec;22(6):820-827. doi: 10.1016/j.pmn.2021.06.002. Epub 2021 Jul 11.
PubMed 34261600Cheung DST, Yeung WF, Suen LK, Chong TC, Ho YS, Yu BY, Chan LY, Chen HY, Lao LX. Self-administered acupressure for knee osteoarthritis in middle-aged and older adults: a pilot randomized controlled trial. Acupunct Med. 2020 Apr;38(2):75-85. doi: 10.1177/0964528419883269. Epub 2019 Nov 13.
PubMed 31718229Guo D, Ma S, Zhao Y, Dong J, Guo B, Li X. Self-administered acupressure and exercise for patients with osteoarthritis: A randomized controlled trial. Clin Rehabil. 2022 Mar;36(3):350-358. doi: 10.1177/02692155211049155. Epub 2021 Oct 18.
PubMed 34658285Ho KK, Kwok AW, Chau WW, Xia SM, Wang YL, Cheng JC. A randomized controlled trial on the effect of focal thermal therapy at acupressure points treating osteoarthritis of the knee. J Orthop Surg Res. 2021 Apr 27;16(1):282. doi: 10.1186/s13018-021-02398-2.
PubMed 33906695Lee WJ, Park H. Effects of auricular acupressure on sleep and pain in elderly people who have osteoarthritis and live in nursing homes: A randomized, single-blind, placebo-controlled trial. Explore (NY). 2023 Mar-Apr;19(2):214-222. doi: 10.1016/j.explore.2022.07.001. Epub 2022 Jul 5.
PubMed 35835645Li LW, Harris RE, Tsodikov A, Struble L, Murphy SL. Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Feb;70(2):221-229. doi: 10.1002/acr.23262. Epub 2017 Dec 29.
PubMed 28437570Sorour AS, Ayoub AS, Abd El Aziz EM. Effectiveness of acupressure versus isometric exercise on pain, stiffness, and physical function in knee osteoarthritis female patients. J Adv Res. 2014 Mar;5(2):193-200. doi: 10.1016/j.jare.2013.02.003. Epub 2013 Apr 8.
PubMed 25685487Kertia N, Asdie AH, Rochmah W, Marsetyawan. Ability of curcuminoid compared to diclofenac sodium in reducing the secretion of cycloxygenase-2 enzyme by synovial fluid's monocytes of patients with osteoarthritis. Acta Med Indones. 2012 Apr;44(2):105-13.
PubMed 22745140Adamczak A, Ozarowski M, Karpinski TM. Curcumin, a Natural Antimicrobial Agent with Strain-Specific Activity. Pharmaceuticals (Basel). 2020 Jul 16;13(7):153. doi: 10.3390/ph13070153.
PubMed 32708619Gomes TPO, Souza JIN, Somerlate LC, Mendonca VA, Lima NM, Carli GP, Castro SBR, de Jesus A S Andrade T, Dias JVL, Oliveira MAL, Alves CCS, Carli AP. Miconia albicans and Curcuma longa herbal medicines positively modulate joint pain, function and inflammation in patients with osteoarthritis: a clinical study. Inflammopharmacology. 2021 Apr;29(2):377-391. doi: 10.1007/s10787-020-00781-9. Epub 2021 Jan 16.
PubMed 33452967Kare SK, Vinay V, Maresz K, Prisk V, Vik H. Tamarindus indica Seed Extract-Based Botanical Compositions Alleviate Knee Pain and Improve Joint Function in Mild-to-Moderate Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. Evid Based Complement Alternat Med. 2022 Jan 19;2022:2226139. doi: 10.1155/2022/2226139. eCollection 2022.
PubMed 35096104Madhu K, Chanda K, Saji MJ. Safety and efficacy of Curcuma longa extract in the treatment of painful knee osteoarthritis: a randomized placebo-controlled trial. Inflammopharmacology. 2013 Apr;21(2):129-36. doi: 10.1007/s10787-012-0163-3. Epub 2012 Dec 16.
PubMed 23242572Pinsornsak P, Niempoog S. The efficacy of Curcuma Longa L. extract as an adjuvant therapy in primary knee osteoarthritis: a randomized control trial. J Med Assoc Thai. 2012 Jan;95 Suppl 1:S51-8.
PubMed 23964444Rahimnia AR, Panahi Y, Alishiri G, Sharafi M, Sahebkar A. Impact of Supplementation with Curcuminoids on Systemic Inflammation in Patients with Knee Osteoarthritis: Findings from a Randomized Double-Blind Placebo-Controlled Trial. Drug Res (Stuttg). 2015 Oct;65(10):521-5. doi: 10.1055/s-0034-1384536. Epub 2014 Jul 22.
PubMed 25050518Raj JP, Venkatachalam S, Racha P, Bhaskaran S, Amaravati RS. Effect of Turmacin supplementation on joint discomfort and functional outcome among healthy participants - A randomized placebo-controlled trial. Complement Ther Med. 2020 Sep;53:102522. doi: 10.1016/j.ctim.2020.102522. Epub 2020 Jul 22.
PubMed 33066856
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combination of Curcuminoid Standardized Turmeric Extract With Acupressure on Inflammatory Markers, Endorphins and Quality of Life in Elderly People With Osteoarthritis Genu
- ClinicalTrials.gov ID
- NCT06105840
- Acronym / sponsor ID
- KE/FK/0674/EC/2023
- Conditions
- Osteoarthritis, Knee
- Keywords
- curcuminoid, acupressure, osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 27 Aug 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to to investigate the efficacy of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers, endorphin hormones in the blood and quality of life in elderly patient with Osteoarthritis Genu.
The main questions it aims to answer are:
- Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to inflammatory markers in elderly patients with Osteoarthritis Genu?
- Is there any effect combination of acupressure and standardized curcuminoids from turmeric extract to endorphin hormones in the blood in elderly patients with Osteoarthritis Genu?
- Is there an effect combination of acupressure and standardized curcuminoids from turmeric extract to quality of life in elderly patients with Osteoarthritis Genu?
Participants in the intervention group received 2 treatments, namely acupressure at points that provide osteoarthritis-specific comfort and standardized curcuminoids from turmeric extract capsules. Participant in the control group alo would receive 2 treatments, an active placebo (starch capsules and sham acupressure).
Researchers will compare interventional group and sham group to see efficacy the combination therapy
Detailed description
Background. One of the degeneration processes that occurs in the elderly is the musculoskeletal system. These deteriorations include bone loss and a decrease in joint fluid volume which is exacerbated by bearing the weight of the body. Pain in Osteoarthritis patients affects many areas of quality of life such as physical function, emotional behavior, and mental health. Osteoarthritis-related pain is a major factor in poor quality of life. The most common pharmacological treatment to control pain is the use of non-steroidal anti-inflammatory drugs (NSAIDs), but these drugs carry the risk of causing side effects. Limitations associated with pharmacologic treatment result in patients choosing commonly available alternative therapies for pain management. Popular alternative therapies include herbal therapy, therapeutic touch, relaxation techniques, music therapy, acupuncture, and acupressure. This alternative therapy, unlike the use of drugs, does not produce dangerous side effects.
Research on the effectiveness of herbal therapy on inflammatory osteoarthritis patients was conducted in Indonesia in 2009 on 80 sufferers with the result that administration of turmeric rhizome extract curcuminoids significantly suppressed the activity of synovial fluid monocytes to secrete Cyclooxygenase-2 (COX-2) and Reactive Oxygen Intermediate (ROI), reduced leukocyte numbers and fluid Malondialdehyde (MDA) levels. synovia and reduces Osteoarthritis (OA) joint pain, with an ability that is not significantly different compared to diclofenac sodium therapy 3x25 mg per day. Furthermore, the development of herbal therapy for Osteoathritis continued with research which proved that the combination of ginger, ginger, soybean and shrimp shell extracts provided significant results in reducing joint pain, stiffness and physical disability which were evaluated based on the Western Ontario and McMaster values. Universities Osteoarthritis Index (WOMAC) and did not show a significant difference when compared with meloxicam.
Research that has been carried out to evaluate the effectiveness of acupressure therapy for the pain of Osteoarthritis patients was also carried out in several countries, including by study on 40 Osteoarthritis patients who were divided into two groups (intervention and control). In the intervention group, acupressure therapy was given for 5 days with a duration of 30 minutes each time. The results showed that the average pain score in the intervention group decreased significantly from 5.89 at the beginning of the study to 4.11 at the end of the study, while the pain score did not change substantially in the control group. These findings remained consistent after adjusting for age, weight, and pretreatment covariates. This study supports the evidence that Acupressure therapy provides an effective option for short-term knee pain relief in patients with knee Osteoarthritis. In line with the results, there was research which was conducted on 51 elderly with osteoarthritis divided into 3 groups (acupressure intervention, placebo and control). This study revealed that respondents who received acupressure therapy for 3-4 weeks with the duration of each therapy being 10-15 minutes, showed a significant reduction in the total WOMAC index, pain and physical dysfunction.
So far, there has been no research combining standardized curcuminoid turmeric extract therapy with acupressure for inflammation and pain in osteoarthritis patients. More clinical trials with appropriate methodology are needed to confirm the effectiveness of standardized turmeric extract, curcuminoids and acupressure to treat physical problems in osteoarthritis patients.
Study Design/Methods. The research will be carried out by design Randomized Controlled Trials (RCT). Respondents will be divided randomly into 2 groups, namely treatment and control. The treatment group will receive interventions, namely herbal therapy and acupressure therapy, while the control group will receive active placebo (capsules containing starch and acupressure massage at points that are not to provide comfort for knee pain). In this study, a double blind technique was used , that is, the subjects and researchers did not know which respondents were in the treatment group and which respondents were in the control group.
Data Analysis Plan
- Analysis Descriptive Data obtained done tabulation in accordance with general data grouping and special data results measurement variable pre-test and post-test research . Data analysis will used For get description general from each variable . Data processing uses distribution frequency , reading data distribution (mean, mode, median, etc deviation )
- Analysis Inferential For know difference effectiveness on second group , researcher use Test the Difference with using the Independent T-Test and Wilcoxon Sign Rank Test. Analysis done on difference all over variable before And after done intervention on second group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Acupressure and Standardized Curcuminoid from Turmeric ExtractGroups assigned randomly using lottery draw number 1 |
| Control Group | Sham comparator | Procedure: Sham Acupressure and PlaceboGroups assigned randomly using lottery draw number 2 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure and Standardized Curcuminoid from Turmeric Extractcapsules containing curcuminoid from Tumeric Extract three times a day for 3 weeks and acupressure massage at points provide comfort for knee pain twice a week for 3 weeks | Procedure or surgery | Intervention Group |
| Sham Acupressure and Placebocapsules containing starch three times a day for 3 weeks and acupressure massage at points that are not to provide comfort for knee pain twice a week for 3 weeks | Procedure or surgery | Control Group |
Primary outcome
Inflammation Marker
Time frame: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy
Inflammation markers are carried out by measuring Leukocyte Number, NLR, Blood Sediment Rate and COX-2 hormone. Outcome measurements will be carried out a complete blood test using a Hematology Analyzer. Leukocyte numbers measured in microliter (mcL). Neutrophil-Lymphocyte Count Ratio can be calculated from the number of neutrophils (cells) and lymphocytes (cells). Neutrophils and lymphocytes will be combined to report Neutrophil-Lymphocyte Count Ratio in %. Blood Sediment Rate is a measurement of the difference in the decrease in height of red blood cells in a test tube (mm) divided by the time (hours) required for all of them to settle to the bottom of the test tube. There will be combined to report Blood Sediment Rate in mm/hr. The COX-2 hormone examination was carried out using the Enzyme Linked Immunosorbent Assay (ELISA). The amount of COX-2 Hormone in the blood in nanograms and blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL
Endorphin Hormones
Time frame: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy
Secretion of endorphin hormones Endorphins, in this case beta endorphin, are hormones released by the pituitary gland in response to stress or pain, which are also secreted in blood plasma. Endorphin hormone examination is carried out using the Enzyme Linked Immunosorbent Assay (ELISA) method on blood plasma. The amount of Endorphin Hormone in the blood in nanograms and the blood sample volume in milliliters will be combined to report secretion of COX-2 in ng/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Results publication: PubMed 34261600Alinaghizadeh M, Hawkins J, Abbassian A, Seif Barghi T, Ayati MH, Alizadeh Vaghasloo M. Effect of Persian acupressure (Ghamz) on Patients with Knee Osteoarthritis: A Single-Blinded Parallel Clinical Trial. Pain Manag Nurs. 2021 Dec;22(6):820-827. doi: 10.1016/j.pmn.2021.06.002. Epub 2021 Jul 11.
- Results publication: PubMed 31718229Cheung DST, Yeung WF, Suen LK, Chong TC, Ho YS, Yu BY, Chan LY, Chen HY, Lao LX. Self-administered acupressure for knee osteoarthritis in middle-aged and older adults: a pilot randomized controlled trial. Acupunct Med. 2020 Apr;38(2):75-85. doi: 10.1177/0964528419883269. Epub 2019 Nov 13.
- Results publication: PubMed 34658285Guo D, Ma S, Zhao Y, Dong J, Guo B, Li X. Self-administered acupressure and exercise for patients with osteoarthritis: A randomized controlled trial. Clin Rehabil. 2022 Mar;36(3):350-358. doi: 10.1177/02692155211049155. Epub 2021 Oct 18.
- Results publication: PubMed 33906695Ho KK, Kwok AW, Chau WW, Xia SM, Wang YL, Cheng JC. A randomized controlled trial on the effect of focal thermal therapy at acupressure points treating osteoarthritis of the knee. J Orthop Surg Res. 2021 Apr 27;16(1):282. doi: 10.1186/s13018-021-02398-2.
- Results publication: PubMed 35835645Lee WJ, Park H. Effects of auricular acupressure on sleep and pain in elderly people who have osteoarthritis and live in nursing homes: A randomized, single-blind, placebo-controlled trial. Explore (NY). 2023 Mar-Apr;19(2):214-222. doi: 10.1016/j.explore.2022.07.001. Epub 2022 Jul 5.
- Results publication: PubMed 28437570Li LW, Harris RE, Tsodikov A, Struble L, Murphy SL. Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Feb;70(2):221-229. doi: 10.1002/acr.23262. Epub 2017 Dec 29.
- Results publication: PubMed 25685487Sorour AS, Ayoub AS, Abd El Aziz EM. Effectiveness of acupressure versus isometric exercise on pain, stiffness, and physical function in knee osteoarthritis female patients. J Adv Res. 2014 Mar;5(2):193-200. doi: 10.1016/j.jare.2013.02.003. Epub 2013 Apr 8.
- Results publication: PubMed 22745140Kertia N, Asdie AH, Rochmah W, Marsetyawan. Ability of curcuminoid compared to diclofenac sodium in reducing the secretion of cycloxygenase-2 enzyme by synovial fluid's monocytes of patients with osteoarthritis. Acta Med Indones. 2012 Apr;44(2):105-13.
- Results publication: PubMed 32708619Adamczak A, Ozarowski M, Karpinski TM. Curcumin, a Natural Antimicrobial Agent with Strain-Specific Activity. Pharmaceuticals (Basel). 2020 Jul 16;13(7):153. doi: 10.3390/ph13070153.
- Results publication: PubMed 33452967Gomes TPO, Souza JIN, Somerlate LC, Mendonca VA, Lima NM, Carli GP, Castro SBR, de Jesus A S Andrade T, Dias JVL, Oliveira MAL, Alves CCS, Carli AP. Miconia albicans and Curcuma longa herbal medicines positively modulate joint pain, function and inflammation in patients with osteoarthritis: a clinical study. Inflammopharmacology. 2021 Apr;29(2):377-391. doi: 10.1007/s10787-020-00781-9. Epub 2021 Jan 16.
- Results publication: PubMed 35096104Kare SK, Vinay V, Maresz K, Prisk V, Vik H. Tamarindus indica Seed Extract-Based Botanical Compositions Alleviate Knee Pain and Improve Joint Function in Mild-to-Moderate Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Clinical Study. Evid Based Complement Alternat Med. 2022 Jan 19;2022:2226139. doi: 10.1155/2022/2226139. eCollection 2022.
- Results publication: PubMed 23242572Madhu K, Chanda K, Saji MJ. Safety and efficacy of Curcuma longa extract in the treatment of painful knee osteoarthritis: a randomized placebo-controlled trial. Inflammopharmacology. 2013 Apr;21(2):129-36. doi: 10.1007/s10787-012-0163-3. Epub 2012 Dec 16.
- The effect of acupressure therapy on pain, stiffness and physical functioning of knees among older adults diagnosed with osteoarthritis: A pilot randomized control trial.Link provided by the sponsor.
- Effectiveness of knee acupressure along with herbal knee poultice for knee osteoarthritis treatment: A pilot pre-post clinical study.Link provided by the sponsor.
- Effects of auricular acupressure on joint pain, range of motion, and sleep in the elderly with knee osteoarthritisLink provided by the sponsor.
- Adjunctive effects of acupressure therapy on pain and quality of life in patients with knee osteoarthritis: an interventional study.Link provided by the sponsor.
- Acujoint, a highly efficient formulation with natural bioactive compounds, exerts potent anti-arthritis effects in human osteoarthritis - A pilot randomized double blind clinical study compared to combination of glucosamine and chondroitinLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Srinalesti Mahanani, Magister principal investigator
Faculty of Medicine University of Gadjah Mada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Acupressure and Standardized Curcuminoid from Turmeric Extract in people with Osteoarthritis, Knee, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation Marker (time frame: Outcome measurements will be carried out before starting therapy and after 3 weeks of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06105840, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.