Title

Role of homoeopathic medicine in the treatment of delayed onset muscle soreness (DOMS) in para-sport players: A double blind randomized control trial

Short Title

Homoeopathic management of Delayed Onset Muscle Soreness in Para-Sport Players

Protocol No.

Version 2

Study Design

Double Blind Randomised Controlled Trial

Proposed Study Center

To be identified

Protocol Details

Approvals:

Approved by 24th Special Committee for Clinical Research (SCCR) held on 20-21st May 2024.

Approved by 77th Scientific Advisory Board (SAB) held on 13th and 14th August 2024.

Approved by 31st Central Ethical Committee held on 18th – 19th November 2024.

Protocol No: 02

Protocol Team:

Principal Investigator: Dr. Harleen Kaur, Research Officer (H)/Scientist- 2, CCRH

Co- Principal Investigator: Dr. Divya Taneja, Research Officer (H)/Scientist- 3, CCRH

Study Mentors: Dr. Subhash Kaushik, Director General, CCRH

Protocol Writing: Dr. Harleen Kaur RO (H)/S-2, Dr. Gurpreet Singh, Senior Research Fellow (H) CCRH

Site investigators:  XXXXXXXXX

Study site: xxxxxxx

Objectives

Primary Objective: To determine the role of individualized homoeopathic treatment in the management of Delayed Onset Muscle Soreness in Para-Sports Players measured through Visual Analogue Scale (VAS) and Likert Scale.

Secondary Objective: To examine the change in pre and post blood and urine samples of the participants for presence of any doping agents in the samples first after 24 hours of starting homoeopathic medication, and then after one week of repeated doses (0, 1 and 7 days).  

Sample size

45 each arm; Total: 90

Inclusion Criteria

Certified Para-sports players of grass root level (non-elite level) of any Para-game and of any gender, between 15 years to 40 years of age with symptoms of DOMS.

At least 2 episodes of DOMS (as per ICD criteria M-79.6) reported in last one year:

Marked discomfort sensation in the upper or lower extremities.

Painful sensation in the upper or lower extremities.

Those who are willing to attend all monitored training sessions at the sports site during the study.

Those who are willing to perform all required physical tests on each occasion, to participate in all fasting blood sample collections.

Those who have not taken any medication (e.g., painkillers, anti-inflammatory) in the last one week, are not taking nutritional supplements with intracellular buffers  that are banned or recognized as doping substances as per NADA/WADA guidelines or consumption of any other illegal substances.

Written Informed consent from the patient.

Exclusion Criteria

Participants on medications like painkillers and anti-inflammatories (NSAIDS) for last one week.

Participants on Disease-modifying ant rheumatic drugs (DMARDS) in last 6 months.

Participants having injuries that can mimic the symptoms of DOMS like fibromyalgia, rheumatoid arthritis, poliomyositis, statins-induced muscle pain etc.

Study Product, dose, route

Individualized Homoeopathic medicines in varied potencies in required doses shall be prescribed to be taken orally, in addition to standard routine care in the treatment group. The standard treatment regimen with additional identical placebo will be prescribed in the standard treatment group.

Study duration; Duration of follow up

1.5 years; (1 year including enrolment and 1 month follow up, 6 months for data compilation)

Statistical Methodology

Data obtained during the study would be verified and analyzed using statistical methods adopted for comparative assessments on randomized patients, in discussion with statistical expert. Repeated measures ANOVA will be used.

Outcome measures

Primary Outcome:

Change in functional recovery through Likert Scale and VAS in both the arms recorded daily for the first week, and then once a week for the remaining 3 weeks.

Change in biomarkers, S. Creatinine kinase, S. Calcium, TNF-alpha and IL-10 (Day 0, Day 7 and Day 31).

Secondary Outcome: Pre-post assessment of blood and urine samples for the presence of pre-identified salts known as doping agents, in various hematological and urological parameters, first at the beginning, then after 24 hours of starting homoeopathic medication, followed by the last sample collection after one week of repeated doses (Day 0, Day 1 and Day 7 of the recruitment).

Financial Budget

Rs. 89 lacs approximately