| CTRI Number |
CTRI/2025/09/095277 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Yoga & Naturopathy Diagnostic Preventive Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga as an Add-on Therapy on Gridhrasi (Sciatica) Patients |
|
Scientific Title of Study
|
To Study the Effect of Yoga as an Add-on Therapy in the management of Gridhrasi W.S.R. to Sciatica |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HEMANT KUMAR KORI |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9713546582 |
| Fax |
|
| Email |
hk75785@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Sunanda Ramkrishna Pedhekar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9423241800 |
| Fax |
|
| Email |
drsrpedhekar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
HEMANT KUMAR KORI |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9713546582 |
| Fax |
|
| Email |
hk75785@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UP |
| UGC NET JRF Fellowship |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa |
| Address |
Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| HEMANT KUMAR KORI |
Sir SunderLal Hospital |
Room No. 21 and 22 Ground Floor Kayachikitsa OPD Indian Medicine Wing Sir SunderLal Hospital Institute of Medical Sciences Banaras Hindu University Varanasi Varanasi UTTAR PRADESH |
9713546582
hk75785@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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Contol Group Vishmushtyadi Vati only |
only Vishmushtyadi Vati will be given for 45 days. 250mg 2 B.D. with Goghrit after food. Yoga will not be given in this group. |
| Intervention |
Experimental Group Yoga Therapy with Vishmushtyadi Vati
|
20 min Yogic Intervention including Sukshma Vyayama & Asanas Followed by Relaxation technique will be given daily for 60 days to the patients and 45 days vishmushtyadi vati with Yoga will be given and remaining 15 days Yoga will be given without Vishmushtyadi vati |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Age criteria between 25 and 64 years with Gridhrasi will be included.
Diagnosed Patients with Classical Symptoms of Gridhrasi of both sex Male & female will be included.
Diagnosed Patients with Classical Symptoms of Gridhrasi irrespective of religion Caste & socioeconomic status will be included.
Diagnosed Patients with Classical Symptoms of Gridhrasi will be included from Sir Sunderlal Hospital IMS BHU.
Willing to Participate in this study. |
|
| ExclusionCriteria |
| Details |
Patients below 25 years and above 64 years will be excluded.
Recent Pelvic surgery or fracture
Pregnant women
Slipped disc
Infectious and Life threatening disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of the disease Gridhrasi by Yoga Therapy with and without Vishmushtyadi Vati
Sign and Symptoms are as follows
1 Ruka
2 Toda
3 Stambha
4 Grahana
5 Spandana
along with
1 Tandra
2 Guruta
3 Arochaka
SLR Test will do assesment
X-ray and MRI if Needed |
60 days study with follow up of every 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assesment of Objective and Subjective criteria by Vas Scale
Effect of Yoga on Gridhrasi will scientifically approve and will made useful in the view of economy. |
60 days study with follow up of every 15 days |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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 4 |
|
Date of First Enrollment (India)
|
07/10/2025 |
| 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="1" Months="6" 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
|
This is an Interventional Study on Patients with Gridhrasi. 110 Diagnosed Patients with classical symptoms of Gridhrasi will be selected by the Randomization method of Lottery. these 110 Patients will be divided into two different Groups respectively Group A Experimental Group and Group B Control Group. 55 Patients in Group A and 55 in Group B. The total treatment duration is 60 days with 4 follow-ups every 15 days. Data will be collected from OPD and IPD of Indian Medicine System Sir SunderLal Hospital IMS BHU Varanasi UP. Intervention of Group A will be Yoga Therapy with Vishmushtyadi Vati and Intervention of Group B will be Vishmushtyadi Vati only. Yoga Therapy will not be given in Group B. The purpose of this study is to check the effect of Yoga Therapy with and without Vishmushtyadi Vati on Gridhrasi Patients. |