A Clinical Study to Assess the Safety and Effectiveness of Dharasana Lep in Patients With Mild to… (NCT07085780) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Safety and Effectiveness of Dharasana Lep in Patients With Mild to Moderate Muscular, Joint, or Rheumatic Pain
India35 participantsStarted 2025-07-28
Plain-language 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.
Who can participate
Age range25 Years – 65 Years
SexALL
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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 - 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 are willing to give written informed consent and are willing to follow the study procedure.
Exclusion criteria
✕. Subject has severe arthritis requiring prescription medication including immunomodulators, COX Inhibitors, etc.
What they're measuring
1
Improvement in Pain Intensity evaluated through Visual Analogue Scale (VAS)
Timeframe: 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).