| CTRI Number |
CTRI/2026/02/103351 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on on pain Trigeminal Neuralgia |
|
Scientific Title of Study
|
Effect of Yoga on Pain and Daily functions in Trigeminal Neuralgia |
| Trial Acronym |
(YOGA-TN Trial) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guatam Sharma |
| Designation |
Professor |
| Affiliation |
All Inida Institute of Medical Sciences |
| Address |
Department of Cardiology
AIIMS
New Delhi
South DELHI 110029 India |
| Phone |
01126593862 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Guatam Sharma |
| Designation |
Professor |
| Affiliation |
All Inida Institute of Medical Sciences |
| Address |
Department of Cardiology
AIIMS
New Delhi
South DELHI 110029 India |
| Phone |
01126593862 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Guatam Sharma |
| Designation |
Professor |
| Affiliation |
All Inida Institute of Medical Sciences |
| Address |
Department of Cardiology
AIIMS
New Delhi
South DELHI 110029 India |
| Phone |
01126593862 |
| Fax |
|
| Email |
drgautamsharma12@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Centre of Integrative Medicine and Reserach |
| Address |
Centre of Integrative Medicine and Reserach office
Room No 7004, 7th floor,
Convergence Block,
AIIMS, New Delhi
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DR GAUTAMSHARMA |
Centre of Integrative Medcicne and Reserach |
Centre of Integrative Medicine and Reserach office
Room No 7004, 7th floor,
Convergence Block,
AIIMS, New Delhi
South DELHI |
01126593862
drgautamsharma12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G500||Trigeminal neuralgia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Medication |
•Pharmacotherapy (anticonvulsants) prescribed as per discretion of treating physician.
•Education on known TN triggers and routine self-care.
•Dose modifications in both study arms will be made as deemed appropriate by the treating physician.
|
| Intervention |
Yoga |
The yoga therapy program is developed based on evidence from previous studies on neuralgia and headaches, which have demonstrated beneficial effects on pain and mental health in patients with migraine and neuralgia. An interdisciplinary team of BNYS specialist at CIMR conducted group discussions to design the current yoga module, drawing upon available literature and the underlying pathophysiological mechanisms of the disease and its progression. The finalized protocol will be subsequently validated by a panel of 11clinical BNYS specialists with or without post graduate degree through a google docform. Their feedback will be documented, and any discrepancies in the proposed yoga asanas will be reviewed and refined to achieve expert consensus
Training Phase : First 2 weeks: 8 supervised yoga sessions of 45 minutes each; given by a yoga therapist at C.I.M.R.
Supervision phase: (3-6 week): 16 Supervised home based online yoga sessions; 4 sessions/week ; each session : 45 minutes each
Query phase/Re-supervision phase: (7-13 week): 21 supervised yoga sessions: (3 classes at CIMR and remaining 18 supervised online sessions:3/week)
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Clinically diagnosed with Trigeminal Neuralgia using :International Classification of Headache Disorders edition 3 (ICHD-3) diagnostic criteria for trigeminal neuralgia.(6)
•Age above 18
•Currently symptomatic individuals experiencing pain attacks on at least three days per week at baseline.
Recently diagnosed patients who are under stable standard medical therapy at least a month after initial diagnosis .
Willing and able to participate in yoga practices.
Able to provide informed consent and comply with study procedures
|
|
| ExclusionCriteria |
| Details |
•Patients who were diagnosed with Secondary TN (Tumours, multiple sclerosis, infection) as classified by International Classification of Headache Disorders edition 3 (ICHD-3) diagnostic criteria for trigeminal neuralgia.(6)
• Planned neurosurgical or ablative procedure for TN during the 3 month intervention period.
•Pregnancy or planning pregnancy within 6 months.
•Clinically diagnosed psychiatric illness or any current severe and uncontrolled psychiatric condition.
•Any other significant Co-morbidity (unstable cardiopulmonary disease, neurological disease (stroke) making the patient unfit for study intervention (conditions judged by investigators to interfere with participation or outcome assessment).
•Patient who did not consent for the trial
•Contraindicated for Yoga therapy
•Current regular yoga practice (greater than 1 session/week in past 3 months).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the intensity of facial pain and its interference with daily life activities among patients with trigeminal neuralgia, measured from using the Penn Facial Scale (PFPS). |
Baseline to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in episodic pain frequency as documented in TN log book from baseline to 3 months.
Change in Depression and Anxiety scores using HADS scale following adjunct yoga intervention from baseline to 3 month.
Changes in medication dosage over a 3 month period.
Change in sleep quality scores using Pittsburgh Sleep Quality Index .
|
Baseline to 3 months |
|
|
Target Sample Size
|
Total Sample Size="160" Sample Size from India="160"
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)
|
01/03/2026 |
| 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="3" 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
|
The proposed trial will be a Prospective, parallel group open-label randomized controlled trial. The study protocol was created incompliance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines. The trial will be prospectively registered in clinical trial registration of India. After completion of the trial the findings will be reported as per the Consolidated Standards of Reporting Trials guidelines. The patients will be screened at Department of Neurology and TN clinic at Centre of Dental Education and Research and Pain clinic at AIIMS New Delhi for patient recruitment, enrolment and randomization. Intervention, Assessment of the patient along with the follow up will be done at Centre for Integrative Medicine and Research All India Institute of Medical Sciences, New Delhi. Patients will be recruited from various departments of the All India Institute of Medical Sciences New Delhi including the Neurology Department, TN Clinic at CDER. After discussing the trial in detail, for interested participants, the informed consent process will be completed by the Principal Investigator, or designated trained research staff.All procedures and interventions will be undertaken shall conform to the Indian Council of Medical Research Good Clinical Practice Guidelines and the principles of the Helsinki declaration. Ethical approval will be obtained from the institutional ethical committee at AIIMS, New Delhi.
The participants will only be enrolled after obtaining written informed consent forms.The participant information sheet mentioning the details including a brief description of the trial, their voluntary participation, benefits, and related risks if any will be provided to the participants for better understanding of the trial. English and Hindi versions of both PICF and PIS will be available for the participants. Legally acceptable representative consent will be obtained from the participant who cannot understand the language. LAR if invited by the participant, can be a parent, friend, or neighbour who understands either English or Hindi and will be able to give consent. The logs will also be maintained to record the number of participants screened, enrolled, and screen failure. The screening log will be used for documenting the record of all participants screened during the enrolment period. The enrolment log will be maintained to document the record of enrolled participants . The Screen Failure Log will be maintained to document the record of the screen failure participants. All the participants will be selected based on the inclusion and exclusion criteria. Post randomisation the participants will be divided into intervention that is yoga arm and control that is standard medical treatment. The Primary outmode is measured using Penn facial tool and and secondary outcomes will be measured using Hospital Anxiety and Depression Scale and Pittsburg sleep quality index. Episodic pain frequency and medication adjusted dosage will also be measured using patient TN diary and log book.The participants will be assessed at baseline and 3 months post intervention. The final data collection period will be at least 48 hours after the last intervention.Potential adverse events will be recorded using log books. The data will be collected in a preplanned proforma. All procedures for the handling and analysis of data will be conducted as per institutional guidelines for the handling and analysis of data for clinical trials.The confidentiality of data will be maintained throughout the study period. All amendments to the study protocol will be notified to the institute ethics committee.The confidentiality of the participant will be ensured by unique identifiers and identifiable information if any will be removed. The data will be maintained in secured database that will be password protected on a secured computer and hard copies of records will be kept in a secured locked place. Patient information will be accessible only to a single primary investigator and stored confidentially.
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