NCT07085780

A Clinical Study to Assess the Safety and Effectiveness of Dharasana Lep in Patients With Mild to Moderate Muscular, Joint, or Rheumatic Pain

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: NovoBliss Research Pvt Ltd · Academic / Other
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
OTHER	LEP	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.

Timeline

• Start date: 2025-07-28
• Primary completion: 2025-09-15
• Completion: 2025-09-15
• First posted: 2025-07-25
• Last updated: 2026-04-13

Locations

1 site across 1 country: India