Treatment of ArthritisPhase 1/2NCT03506919
Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine for the Management of Arthritis
A Phase 1/2 study testing Allopurinol in people with Treatment of Arthritis, run by Shifa Ul Mulk Memorial Hospital at 1 site in Pakistan.
Trial summary
This study aimed to develop two poly herbal capsule formulations for arthritis through granulation and conduction of their clinical trial in order to achieve quality, efficacy and safety. Arthritis is a chronic disease of unknown cause. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Treatment of Arthritis
- What is being tested?
- Allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2018to 30 Jun 2018
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients suffering from Arthritis
Who cannot join
- Patients with Hypertension, Cardiovascular disorders and Kidney disorders were excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
clinical trial was conducted in Bahawalpur, and Rawalpindi
Bahawalpur, Punjab Province, 062
Muhammad Asif, Ph.D, 923346911256, doctor.asif101@gmail.com
Muhamamd Bilal, M. PHil
About this study
Official title: Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine Arthitec 1 and Arthitec 2 With Allopathic Medicine for the Management of Arthritis
This study aimed to develop two poly herbal capsule formulations for arthritis through granulation and conduction of their clinical trial in order to achieve quality, efficacy and safety. Arthritis is a chronic disease of unknown cause. An inflammatory disease of the synovium, it results in pain, stiffness, swelling, deformity and, eventually, loss of function in the joints. Despite early detection, current treatment medications are limited in their efficacy and are frequently toxic. Many patients look for complementary and alternative medicine (CAM) options in coping with this debilitating disease. Research has indicated that people suffering from chronic pain, as in arthritis, and those dissatisfied with current treatment are very likely to seek alternative treatments, and an estimated 60-90% of persons with arthritis use complementary and alternative medicines. Among the most widely used treatments are chiropractic and herbal therapies. This growing interest in alternative medical practices clearly indicates the need for more thorough investigation into the safety and efficacy of herbal medicine. Thousand years of traditional use can provide us with valuable guidelines to the selection, preparation and application of herbal formulation. To be accepted as viable alternative to modern medicine, the same vigorous method of scientific and clinical validation must be applied to prove the safety and effectiveness of a therapeutical product.
Read the detailed description
Although there are more than 100 different kinds of arthritis, the three most common are gout, osteoarthritis (OA) and rheumatoid arthritis (RA).Gout occurs in response to the presence of monosodium urate (MSU) crystals in joints, bones and soft tissues, and is usually treated by non-steroidal anti-inflammatory drugs (NSAIDs), oral or intravenous colchicines, and oral, intravenous or intraarticular glucocorticoids. All these drugs can abort acute attacks, but they also may have severe side effects. OA results from articular cartilage failure induced by a combination of genetic, metabolic, biochemical and biomechanical factors. OA is normally treated with analgesics such as acetaminophen and opioids, NSAIDs, and intraarticular therapies such as glucocorticoids and hyaluronans.
In RA, 75% of the sufferers are women, suggesting the importance of hormones in the etiology of the disease. Smoking and stress are also thought to contribute to this disease, which is characterized by joint stiffness and swelling, often in a symmetrical pattern on both sides of the body. The goals of management of patients with RA are to control pain and swelling, delay disease progression, minimize disability, and improve quality of life. For pain control and swelling, treatment includes analgesics such as acetaminophen and opioids, NSAIDs, and intra-articular therapies such as glucocorticoids. In addition, disease modifying anti-rheumatic drugs (DMARDs) are used to modify the clinical and radiological course of RA. Examples include methotrexate (MTX), sulfasalazine, leflunomide, hydroxychloroquine and newer therapies such as anti-tumor necrosis factor (TNF)-a therapy (etanercept, infliximab and adalimumab), anti-CD20 therapy (rituximab) and abatacept However, all of these agents are associated with numerous side effects Promising evidence has been found for the effective use of some herbal preparations in the treatment of arthritis. Furthermore, evidence suggesting that some herbal preparations reduce consumption of non-steroidal anti-inflammatory drugs. It has been evident that some herbal preparations (Tripterygium wilfordii Hook F) monotherapy is not inferior then methotrexate and in combination with methotrexate showed better result than alone. In addition, adverse effect associated with trials of herbal preparation for arthritis is not only fewer but also minor. Evidence-based complementary and alternative medicine treatments are remarkably successful in addressing not only chronic but acute health issues as well. It is strongly perceived that different complementary and alternative medicine treatments exerts their healing potential by influencing immune system.
- Conditions
- Treatment of Arthritis
- Being tested
- Allopurinol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Allopurinol is used to treat gout and certain types of kidney stones. It is also used to prevent increased uric acid levels in patients receiving cancer chemotherapy. These patients can have increased uric acid levels due to release of uric acid from the dying cancer cells. Allopurinol works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout and kidney problems
| Study group | Role | What they receive |
|---|---|---|
| Arthitec 1 | Experimental | Not described Receives: Drug: Allopurinol |
| Arthitec 2 | Experimental | Not described Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Serum Uric Acid level
Reduction in Serum Uric Acid level will be monitored after 8 weeks. Increase level of Serum Uric acid is the major cause of Gouty arthritis which is more prevalent in South-Asian countries.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start1 Jan 2018
- Primary completion30 Apr 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment of ArthritisStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shifa Ul Mulk Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiz Muhammad Asif, Shifa Ul Mulk Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506919
- Sponsor's protocol ID
- 003
- Status last verified
- Apr 2018
- First submitted
- 12 Jan 2018
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Efficacy and Safety of Coded Polyherbal Medicine Arthitec 1 and Arthitec 2 With Allopathic Medicine for the Management of Arthritis
- ClinicalTrials.gov ID
- NCT03506919
- Acronym / sponsor ID
- 003
- Conditions
- Treatment of Arthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shifa Ul Mulk Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Apr 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 24 Apr 2018 (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.
This study aimed to develop two poly herbal capsule formulations for arthritis through granulation and conduction of their clinical trial in order to achieve quality, efficacy and safety. Arthritis is a chronic disease of unknown cause. An inflammatory disease of the synovium, it results in pain, stiffness, swelling, deformity and, eventually, loss of function in the joints. Despite early detection, current treatment medications are limited in their efficacy and are frequently toxic. Many patients look for complementary and alternative medicine (CAM) options in coping with this debilitating disease. Research has indicated that people suffering from chronic pain, as in arthritis, and those dissatisfied with current treatment are very likely to seek alternative treatments, and an estimated 60-90% of persons with arthritis use complementary and alternative medicines. Among the most widely used treatments are chiropractic and herbal therapies. This growing interest in alternative medical practices clearly indicates the need for more thorough investigation into the safety and efficacy of herbal medicine. Thousand years of traditional use can provide us with valuable guidelines to the selection, preparation and application of herbal formulation. To be accepted as viable alternative to modern medicine, the same vigorous method of scientific and clinical validation must be applied to prove the safety and effectiveness of a therapeutical product.
Detailed description
Although there are more than 100 different kinds of arthritis, the three most common are gout, osteoarthritis (OA) and rheumatoid arthritis (RA).Gout occurs in response to the presence of monosodium urate (MSU) crystals in joints, bones and soft tissues, and is usually treated by non-steroidal anti-inflammatory drugs (NSAIDs), oral or intravenous colchicines, and oral, intravenous or intraarticular glucocorticoids. All these drugs can abort acute attacks, but they also may have severe side effects. OA results from articular cartilage failure induced by a combination of genetic, metabolic, biochemical and biomechanical factors. OA is normally treated with analgesics such as acetaminophen and opioids, NSAIDs, and intraarticular therapies such as glucocorticoids and hyaluronans.
In RA, 75% of the sufferers are women, suggesting the importance of hormones in the etiology of the disease. Smoking and stress are also thought to contribute to this disease, which is characterized by joint stiffness and swelling, often in a symmetrical pattern on both sides of the body. The goals of management of patients with RA are to control pain and swelling, delay disease progression, minimize disability, and improve quality of life. For pain control and swelling, treatment includes analgesics such as acetaminophen and opioids, NSAIDs, and intra-articular therapies such as glucocorticoids. In addition, disease modifying anti-rheumatic drugs (DMARDs) are used to modify the clinical and radiological course of RA. Examples include methotrexate (MTX), sulfasalazine, leflunomide, hydroxychloroquine and newer therapies such as anti-tumor necrosis factor (TNF)-a therapy (etanercept, infliximab and adalimumab), anti-CD20 therapy (rituximab) and abatacept However, all of these agents are associated with numerous side effects Promising evidence has been found for the effective use of some herbal preparations in the treatment of arthritis. Furthermore, evidence suggesting that some herbal preparations reduce consumption of non-steroidal anti-inflammatory drugs. It has been evident that some herbal preparations (Tripterygium wilfordii Hook F) monotherapy is not inferior then methotrexate and in combination with methotrexate showed better result than alone. In addition, adverse effect associated with trials of herbal preparation for arthritis is not only fewer but also minor. Evidence-based complementary and alternative medicine treatments are remarkably successful in addressing not only chronic but acute health issues as well. It is strongly perceived that different complementary and alternative medicine treatments exerts their healing potential by influencing immune system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthitec 1 | Experimental | Drug: Allopurinol |
| Arthitec 2 | Experimental | Drug: Allopurinol |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients suffering from Arthritis
Key exclusion criteria (1 listed)
- Patients with Hypertension, Cardiovascular disorders and Kidney disorders were excluded
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 |
|---|---|---|
| AllopurinolAllopurinol is used to treat gout and certain types of kidney stones. It is also used to prevent increased uric acid levels in patients receiving cancer chemotherapy. These patients can have increased uric acid levels due to release of uric acid from the dying cancer cells. Allopurinol works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout and kidney problems | Drug | Arthitec 1, Arthitec 2 |
Primary outcome
Reduction in Serum Uric Acid level
Time frame: 8 weeks
Reduction in Serum Uric Acid level will be monitored after 8 weeks. Increase level of Serum Uric acid is the major cause of Gouty arthritis which is more prevalent in South-Asian countries.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
clinical trial was conducted in Bahawalpur, and Rawalpindi
Bahawalpur, Pakistan
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 Allopurinol in people with Treatment of Arthritis, run by Shifa Ul Mulk Memorial Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 24 Apr 2018. 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 Pakistan. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Serum Uric Acid level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2018.