| CTRI Number |
CTRI/2026/02/103251 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic management of Anxiety during sports in Para-sports players |
|
Scientific Title of Study
|
Role of Individualized Homoeopathic medicine in the management of Competition Anxiety in Para-sports players – A multicentric double blind, randomised, controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harleen Kaur |
| Designation |
Research Officer (Hom)/Scientist-2 |
| Affiliation |
Central Council for Research In Homoeopathy |
| Address |
Central Council for Research In Homoeopathy, Room No - 313, 3rd Floor 61- 65, D
Block, Institutional Area, Janakpuri
West
DELHI
110058
India |
| Phone |
9818709729 |
| Fax |
|
| Email |
dr.harleenkaur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harleen Kaur |
| Designation |
Research Officer (Hom)/Scientist-2 |
| Affiliation |
Central Council for Research In Homoeopathy |
| Address |
Central Council for Research In Homoeopathy, Room No - 313, 3rd Floor 61- 65, D
Block, Institutional Area, Janakpuri
DELHI
110058
India |
| Phone |
9818709729 |
| Fax |
|
| Email |
dr.harleenkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harleen Kaur |
| Designation |
Research Officer (Hom)/Scientist-2 |
| Affiliation |
Central Council for Research In Homoeopathy |
| Address |
Central Council for Research In Homoeopathy, Room No - 313, 3rd Floor 61- 65, D
Block, Institutional Area, Janakpuri
DELHI
110058
India |
| Phone |
9818709729 |
| Fax |
|
| Email |
dr.harleenkaur@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy |
|
|
Primary Sponsor
|
| Name |
Central Council for Research In Homoeopathy |
| Address |
Central Council for Research in Homoeopathy, 61-65, D-Block, Institutional Area, Janakpuri, Delhi - 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Kirubhakar Raja |
Site Identified By Tamil Nadu Para Sports Association |
Raja Muthiah Road,
Periamet, Kannappar Thidal,
Choolai, Chennai - 600003
Tamil Nadu
Chennai
TAMIL NADU |
9500244444
rajavicotory68@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, N.I.E.P.M.D., Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Competition Anxiety |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicine |
Homoeopathic medicines to be used in the trial are known pharmacopoeial preparations. The medicines will be administered orally. The medicine will be repeated depending on the potency and complaints of the patient in accordance with the principles of homoeopathy. Once the improvement sets in, placebo is to be continued till the medicine continues to act for 6 months. |
| Comparator Agent |
Placebo |
The standard treatment regimen with additional identical placebo will be prescribed in the standard treatment group for 6 months. The placebo will be administered orally. The Placebo will be repeated twice or thrice a day for maximum of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
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 more than 17.
Written Informed consent from the participants.
|
|
| ExclusionCriteria |
| Details |
The Sport Competition Anxiety Test (SCAT) SCORE less than 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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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). |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impact of Anxiety on the respective achievements/ goals of the para-athletes. |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
| 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.) | |