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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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