CTRI/2025/07/091299
Completed
Not Applicable
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.
Shah Maganlal Chunilal Gandhi1 site in 1 country35 target enrollmentStarted: July 31, 2025Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shah Maganlal Chunilal Gandhi
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- 1. To evaluate the effectiveness of the test treatment by assessing the change in pain intensity i.e. knee pain, swelling, back pain, muscle pain, sprains and strains from baseline before application of test treatment to post removal of test treatment.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 25.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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 to 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.
- •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 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.
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
1. To evaluate the effectiveness of the test treatment by assessing the change in pain intensity i.e. knee pain, swelling, back pain, muscle pain, sprains and strains from baseline before application of test treatment to post removal of test treatment.
Time Frame: Day 01, Day 02 and Day 04(2 Days)
Secondary Outcomes
- 1. To evaluate the effectiveness of the test treatment by assessing change in joint stiffness and movement from baseline before application of test treatment to post removal of test-treatment(Day 01 and Day 04)
- 2. To evaluate the effectiveness of the test treatment by assessing change in flexibility/extent of movement of joint from baseline before application of test treatment to post removal of test-treatment.(Day 01 and Day 04)
- 3. To evaluate the effectiveness of the test treatment by assessing the change in Vedana (pain) from baseline before application of test treatment to post removal of test-treatment.(Day 01 and Day 04)
- 4. To evaluate the effectiveness of the test treatment by accessing the change in ayurvedic clinical examination from baseline before application of test treatment to post removal of test-treatment(Day 01 and Day 04)
- 5. To evaluate the effectiveness of the test treatment by assessing change in product perception questionnaire, and PGIC questionnaire from baseline before application of test treatment to post removal of test treatment.(Day 01 and Day 04)
Investigators
Dr Harsh Raval
NovoBliss Research Private Limited
Study Sites (1)
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