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Clinical Trial Details

Effect of personalised ayurveda treatment in Duchenne Muscular Dystrophy: A 3 year study



Study Phase

Phase 1/Phase 2

Enrollment

45

Study Sites

45

Study Duration

4



About the Trial

Effect of personalised ayurveda treatment in Duchenne Muscular Dystrophy: A 3 year study


Detailed Description


Study Timeline & Recruitment

Recuitment Start

2026-07-14

Recuitment End

2026-07-16

Study Start

2026-07-15

Primary Completion

2026-07-22

Study Completion

2026-07-16


Sample Size

Enrollment Type

Actual

Target Sample Size

120

Current Enrollment

45

Study Arms

4

Sample Size Justification

test


Study Sites

Site Name City State Country Principal Investigator
AVP Research Foundation Coimbatore Tamil Nadu India Dr. Somit
A.V.P. MULTI SPECIALITY CLINIC Coimbatore Tamil Nadu India Dr. Somit
AVP Ayurveda Clinic Coimbatore Tamil Nadu India Dr. Somit

Ethics & Regulatory

Ethics Approval Yes
Ethics Committee Name AVP Institutional Ethics Committee
Approval Number IEC/AVPRF/2026/025
Approval Date 2026-07-13
Regulatory Approval Yes
Regulatory Authority Ministry of AYUSH
Regulatory Approval Number AYUSH/CT/2026/115
Regulatory Approval Date 2026-07-15

Eligibility Criteria

Inclusion Criteria

• Male or female aged 40–70 years • Diagnosed with Knee Osteoarthritis • Willing to provide written informed consent • Able to attend follow-up visits

Gender all
Minimum Age 40 Years
Maximum Age 70 Years
Healthy Volunteers yes
Exclusion Criteria

• Pregnancy or lactation • History of knee replacement surgery • Severe cardiac disease • Known allergy to Ashwagandha • Participation in another clinical trial

Investigator Type Principal Investigator
Investigator Name Dr. Ramesh Kumar
Qualification MD (Ayurveda)
Designation Senior Research Officer
Institution AVP Research Foundation
Department Kayachikitsa
Email ramesh@avpresearch.org
Phone 9840616100
Investigator Type Scientific Contact
Investigator Name Ramesh kumar
Qualification M.S (Ayu), M.Sc, PGDPH
Designation Senior Research Officer
Institution AVP Research Foundation
Department Kayachikitsa
Email ramesh@avpresearch.org
Phone 9840616100
Primary Objective

To evaluate the efficacy of Ashwagandha Churna in reducing pain and improving joint function in Knee Osteoarthritis patients.

Secondary Objectives

To assess improvement in quality of life. To evaluate improvement in walking distance. To assess reduction in analgesic use.

Exploratory Objectives

To evaluate changes in inflammatory biomarkers.

Primary Outcomes

Outcome Measure: Pain Score

Time Frame: 12 Weeks

Assessment Method: WOMAC

Outcome Measure: Flexibility

Time Frame: 12 Week

Assessment Method: Goniometer

Outcome Measure: Quality of Life

Time Frame: 24 Weeks

Assessment Method: SF-36

Secondary Outcomes

No Secondary Outcomes Available.

Sponsors & Support

Primary Sponsor Name AVP
Sponsor Type Self Funded
Country India
Documents

No Documents Available.

Trial Status

Ongoing
CTRI Number CTRI/2026/07/06874
Registered on 01-01-1970
Last Updated 01-01-1970
Recruitment Start Date 14-07-2026
Estimated Completion 29-07-2026
CTRI Website

Key information

Study Type Interventional
Study Design
Allocation Randomized
Masking Open Label
Control Type Active Control
Primary Purpose Prevention

Need More Information?

If you are interested in participating or have any questions about the this trial, please contact us.

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