Musculoskeletal PainNCT07085780
A Clinical Study to Assess the Safety and Effectiveness of Dharasana Lep in Patients With Mild to Moderate Muscular, Joint, or Rheumatic Pain
A study testing LEP in people with Musculoskeletal Pain and Rheumatic Pain, run by NovoBliss Research Pvt Ltd at 1 site in India.
Trial summary
A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients with Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Musculoskeletal Pain, Rheumatic Pain
- What is being tested?
- LEP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIndia
- Study dates
- 28 Jul 2025to 15 Sep 2025
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 25-65 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Subject is in good general health as determined by the Investigator on the basis of medical history.
- Subject must be having presence of body ache, joint or muscle pain, sprain/strain, or back pain for more than 1 week and less than 6 months.
- Patients must have a confirmed diagnosis of mild to moderate musculoskeletal pain and rheumatic conditions with a pain score between 4 - 7, grade will be evaluated using Visual Analog Scale (VAS).
- Subject is able to remain on stable doses of contraceptive or replacement hormonal therapy, including no therapy, 6 weeks prior to and for the duration of the study.
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- If the subject is of childbearing potential they must have a self-reported negative urine pregnancy, is practicing and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms with spermicide or sponge with spermicidal jelly, cream or foam, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
- Subjects are willing to give written informed consent and are willing to follow the study procedure.
- Subjects who commit not to use any other medicated/ prescription topical analgesics or medication, other than the test treatment for the entire duration of the study.
- Subject is willing and able to comply with study procedures, including all scheduled visits, treatment applications, and assessments.
- Subject is willing and able to follow the study directions, to participate in the study, returning for all specified visits.
- Subject must be able to understand and provide written informed consent to participate in the study.
Who cannot join
- Subject has severe arthritis requiring prescription medication including immunomodulators, COX Inhibitors, etc.
- Subjects having any skin disorder or presence of open wounds, cut, bruising, rashes etc.
- Subjects with raw wounds, sutures, fractures and hematoma.
- Subjects suffering from auto-immune disorder, spastic disorder, genetic disorder and any other sever traumatic conditions.
- Subjects with chronic pain like arthritis, gout, and ankylosing spondylitis.
- Subject have history of any hypersensitivity to the ingredients in the Lep.
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- Subject who had taken any systemic product for any illnesses for at least 3 months.
- History of alcohol or drug addiction.
- Pregnant or breast feeding or planning to become pregnant during the study period.
- History of chronic illness which may influence the cutaneous state.
- Subject have participated any clinical research study within the last 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients With Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis.
A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients with Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis.
Read the detailed description
This is an open-label, single-centre, prospective, interventional, clinical study to evaluate the efficacy and safety of pain relief lep in patients with mild to moderate musculoskeletal pain and rheumatoid arthritis. A total of 35 participants will be enrolled in the study, including males and non-pregnant, non-lactating females aged between 25 and 65 years (inclusive). Participants experiencing musculoskeletal pain of mild to moderate intensity, such as knee pain, swelling, back pain, muscle sprains, or strains will be enrolled in the study. Among the total, 5 participants will have a diagnosis of Rheumatoid Arthritis with associated walking difficulty. The study aims to complete with 30 evaluable participants, accounting for potential dropouts or withdrawals during the study period.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by recruiting department prior the enrolment visit. During the screening process (prior to enrolment), participants will be instructed to refrain from using any other topical analgesics or pain relief medications before and throughout the study period.
There will be a total of 2 visits during the study - Visit 01 (01 Day) and Visit 02 (04 Day). The duration of the study will be 04 Days (2 Days) from the enrolment. Subjects will be instructed to visit the facility as per below visits.
- Conditions
- Musculoskeletal Pain, Rheumatic Pain
- Being tested
- LEP
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEPOther
- Apply a thin, even layer of the Lep directly onto the clean and dry affected area.
- Cover the application with a layer of clean cotton.
- Allow the Lep to remain on the area for at least 2 days,
- Avoiding exposure to direct heat or open flame during this period.
- In this study, on Day 04, gently remove the Lep using warm water and soft cotton cloth and thoroughly cleanse the area with mild soap and water.
| Study group | Role | What they receive |
|---|---|---|
| Dharasena Pain Relief Lep | Experimental | 1. Apply a thin, even layer of the Lep directly onto the clean and dry affected area.
2. Cover the application with a layer of clean cotton.
3. Allow the Lep to remain on the area for at least 2 days,
4. Avoiding exposure to direct heat or open flame during this period.
5. In this study, on Day 04, gently remove the Lep using warm water and soft cotton cloth and thoroughly cleanse the area with mild soap and water. Receives: Other: LEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Pain Intensity evaluated through Visual Analogue Scale (VAS)
The Visual Analogue Scale is a 10 point scale. In which 0 means no pain and 10 means severe pain.
Measured: From baseline prior to application of test treatment on Day 01, telephonic follow up on Day 02 and post removal of test treatment on Day 04 (+2 Days).
Secondary outcomes (5)
Improvement in Joint stiffness and movement evaluated through Numeric Pain Rating Scale (NPRS)
The Numeric Pain Rating Scale is a 10 point scale. In which 0 means no pain and 10 means severe pain.
Measured: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in flexibility / extent of movement of joint evaluated through Range of Motion (ROM) assessment
Measured: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in Vedana assessment and management evaluated through Ayurvedic Pain Assessment and Management scale (APMS)
Measured: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in aggravated doshas (Vata, Pitta, Kapha) evaluated through ayurvedic clinical examination
Improvement in aggravated Doshas (Vata, Pitta, Kapha) will be assessed using a standardized Ayurvedic clinical examination scale, based on classical signs and symptoms. Each Dosha will be graded on a 4-point scale (0-3) indicating severity from absent to severe.
Measured: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in product perception questionnaire using quality of life questionnaire through 5-point Likert scale to evaluate the changes in pain intensity, joint movement, stiffness, musculoskeletal pain and inflammation post treatment and PGIC scale
Measured: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start28 Jul 2025
- Primary completion15 Sep 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovoBliss Research Pvt Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Shah Maganlal Chunilal Gandhi
- Responsible party
- Sponsor
- Investigators
- Dr. Nayan Patel, Principal investigator, NovoBliss Research Private Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085780
- Sponsor's protocol ID
- NB250029-SM
- Status last verified
- Jul 2025
- First submitted
- 9 Jul 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients With Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT07085780
- Acronym / sponsor ID
- NB250029-SM
- Conditions
- Musculoskeletal Pain, Rheumatic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- NovoBliss Research Pvt LtdUniversity, hospital or other
- Collaborators
- Shah Maganlal Chunilal Gandhi
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 25 Jul 2025 (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.
A Prospective, Open-Label, Single-Centre Interventional Study to Evaluate the Efficacy and Safety of Dharasana Lep in Patients with Mild to Moderate Musculoskeletal Pain and Rheumatoid Arthritis.
Detailed description
This is an open-label, single-centre, prospective, interventional, clinical study to evaluate the efficacy and safety of pain relief lep in patients with mild to moderate musculoskeletal pain and rheumatoid arthritis. A total of 35 participants will be enrolled in the study, including males and non-pregnant, non-lactating females aged between 25 and 65 years (inclusive). Participants experiencing musculoskeletal pain of mild to moderate intensity, such as knee pain, swelling, back pain, muscle sprains, or strains will be enrolled in the study. Among the total, 5 participants will have a diagnosis of Rheumatoid Arthritis with associated walking difficulty. The study aims to complete with 30 evaluable participants, accounting for potential dropouts or withdrawals during the study period.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining the written informed consent from the study participants. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called on the telephone by recruiting department prior the enrolment visit. During the screening process (prior to enrolment), participants will be instructed to refrain from using any other topical analgesics or pain relief medications before and throughout the study period.
There will be a total of 2 visits during the study - Visit 01 (01 Day) and Visit 02 (04 Day). The duration of the study will be 04 Days (2 Days) from the enrolment. Subjects will be instructed to visit the facility as per below visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dharasena Pain Relief Lep | Experimental | Other: LEP1. Apply a thin, even layer of the Lep directly onto the clean and dry affected area. 2. Cover the application with a layer of clean cotton. 3. Allow the Lep to remain on the area for at least 2 days, 4. Avoiding exposure to direct heat or open flame during this period. 5. In this study, on Day 04, gently remove the Lep using warm water and soft cotton cloth and thoroughly cleanse the area with mild soap and water. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age: 25-65 years (both inclusive) at the time of consent.
- Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
- Subject is in good general health as determined by the Investigator on the basis of medical history.
- Subject must be having presence of body ache, joint or muscle pain, sprain/strain, or back pain for more than 1 week and less than 6 months.
- Patients must have a confirmed diagnosis of mild to moderate musculoskeletal pain and rheumatic conditions with a pain score between 4 - 7, grade will be evaluated using Visual Analog Scale (VAS).
Key exclusion criteria (11 listed)
- Subject has severe arthritis requiring prescription medication including immunomodulators, COX Inhibitors, etc.
- Subjects having any skin disorder or presence of open wounds, cut, bruising, rashes etc.
- Subjects with raw wounds, sutures, fractures and hematoma.
- Subjects suffering from auto-immune disorder, spastic disorder, genetic disorder and any other sever traumatic conditions.
- Subjects with chronic pain like arthritis, gout, and ankylosing spondylitis.
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 |
|---|---|---|
| LEP1. Apply a thin, even layer of the Lep directly onto the clean and dry affected area. 2. Cover the application with a layer of clean cotton. 3. Allow the Lep to remain on the area for at least 2 days, 4. Avoiding exposure to direct heat or open flame during this period. 5. In this study, on Day 04, gently remove the Lep using warm water and soft cotton cloth and thoroughly cleanse the area with mild soap and water. | Other | Dharasena Pain Relief Lep |
Primary outcome
Improvement in Pain Intensity evaluated through Visual Analogue Scale (VAS)
Time frame: From baseline prior to application of test treatment on Day 01, telephonic follow up on Day 02 and post removal of test treatment on Day 04 (+2 Days).
The Visual Analogue Scale is a 10 point scale. In which 0 means no pain and 10 means severe pain.
5 secondary outcomes
Improvement in Joint stiffness and movement evaluated through Numeric Pain Rating Scale (NPRS)
Time frame: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in flexibility / extent of movement of joint evaluated through Range of Motion (ROM) assessment
Time frame: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in Vedana assessment and management evaluated through Ayurvedic Pain Assessment and Management scale (APMS)
Time frame: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in aggravated doshas (Vata, Pitta, Kapha) evaluated through ayurvedic clinical examination
Time frame: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Improvement in product perception questionnaire using quality of life questionnaire through 5-point Likert scale to evaluate the changes in pain intensity, joint movement, stiffness, musculoskeletal pain and inflammation post treatment and PGIC scale
Time frame: From baseline prior to application of test treatment on Day 01, and post removal of test treatment on Day 04 (+2 Days).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Dr. Nayan Patel principal investigator
NovoBliss Research Private Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEP in people with Musculoskeletal Pain and Rheumatic Pain, run by NovoBliss Research Pvt Ltd at 1 site in India.
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 12 inclusion and 11 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: finished, as of the sponsor's last update on 13 Apr 2026. 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 India. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Pain Intensity evaluated through Visual Analogue Scale (VAS) (time frame: From baseline prior to application of test treatment on Day 01, telephonic follow up on Day 02 and post removal of test treatment on Day 04 (+2 Days).). 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 13 Apr 2026.