Role of Individualized Homoeopathic medicine in the management of Competition Anxiety in Para-sports players – A multicentric double blind, randomised, controlled trial

Title

Role of Individualized Homoeopathic medicine in the management of Competition Anxiety in Para-sports players – A multicentric double blind, randomised, controlled trial

|Short Title

Homoeopathic management of Competition Anxiety in Para-sports 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. Divya Taneja Research Officer (H)/Scientist- 3, CCRH

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

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

Protocol Development Team: Dr. Divya Taneja, Dr. Harleen Kaur, Dr. Twinkle Goyal, Senior Research Fellow (H) CCRH, Dr. Gurpreet Singh, Research Associate (H) CCRH

Site investigators:

Dr. D. Karthikeyan/Scientist – 3, Officer In-Charge, Homoeopathy Research Institute for Disabilities, Chennai

Mr. Kirubhakar Raja, Tamil Nadu Para Sports Association

Dr. Shivakumar Kanan, Sports Pharmacist, Chennai

XXX, PHYSIOTHERAPIST (To be recruited)

XXX, HOMOEOPATHIC DOCTOR (To be recruited)

XXX, COACH/ SITE IN-CHARGE (To be recruited)

Study site:xxxxxxx

|Objectives

Primary Objective:

To determine the role of individualized homoeopathic treatment in the management of Competition Anxiety in Para-sports players.

Secondary Objective:

To evaluate whether the management of anxiety have any direct impact on the respective achievements/ goals of the para-athletes.

|Sample size

45 each arm; Total: 90

|Inclusion Criteria

• Certified Para-sports players of any Para-game and of any gender, between 15 years to 40 years of age with Competition Anxiety.
• The Sport Competition Anxiety Test (SCAT) SCORE > 17.
• Written Informed consent from the participants.

|Exclusion Criteria

• The Sport Competition Anxiety Test (SCAT) SCORE <17
• Failing disability test as per disability norms in The Rights of Persons with Disabilities Act, 2016 (RPWD)
• Participants taking any anti-anxiety medicines or any corticosteroids in last 3 months.
• Participants with thyroid dysfunction.

|Study Product, dose, route

Individualized Homoeopathic medicines tested and certified by NFSU (to be free from WADA banned substances) 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

2 years; (1 year including enrolment and follow up, and 6 months for data compilation and 6 months for manuscript writing and publication). The follow up period of each player will be 3 months.

|Statistical Methodology

Data obtained during the study would be verified and analyzed using statistical methods adopted for comparative assessments on randomized participants, in discussion with statistical expert.

|Outcome measures

Primary Outcome: Assessment of Competition Anxiety through The Sport Competition Anxiety Test (SCAT) (at baseline, weekly before any big tournament, one day before the game, and after the targeted tournament, then monthly; total duration of the follow-ups will be 6 months).

Secondary outcome: Impact of Anxiety on the respective achievements/ goals of the para-athletes.

|Financial Budget

Rs. 83 Lacs (Approx.)