| CTRI Number |
CTRI/2025/05/086899 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluate the efficacy of Vishwadi Guggulu in the management of Grudhrasi (Sciatica) |
|
Scientific Title of Study
|
Randomised controlled clinical trial to evaluate the efficacy of Vishwadi Guggulu in the management of Grudhrasi (Sciatica) |
| Trial Acronym |
interventional |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Genu Muthe |
| Designation |
Pg Scholar |
| Affiliation |
|
| Address |
OPD no 13 KAYACHIKITSA department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8999114735 |
| Fax |
|
| Email |
msagar8457@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Badarkhe Amol Motiram |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
OPD no 13 KAYACHIKITSA department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8999114735 |
| Fax |
|
| Email |
dr.amolb1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sagar Genu Muthe |
| Designation |
Pg Scholar |
| Affiliation |
|
| Address |
OPD no 13 KAYACHIKITSA department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8999114735 |
| Fax |
|
| Email |
msagar8457@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
C S.M.S.S Ayurved Mahavidyalaya |
| Address |
Kanchanwadi, Aurangabad Maharashtra 431011 |
| Type of Sponsor |
Private 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 |
| Dr Sagar Genu Muthe |
C.S.M.S.S Ayurved Mahavidyalaya |
OPD NO 13 KAYACHIKITSA Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya KANCHANWADI Aurangabad 431011
Aurangabad
MAHARASHTRA |
8999114735
msagar8457@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VISHWADI GUGGULU , Reference: Bharat Bhaisajya Ratnakar , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Koshnajal ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: SHEFALIPATRA KWATH , Reference: Bhavaprakash Madhyam Khanda, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of Age group 30 to 60 years will be selected
2) Patients showing classical Lakshana of Grudhrasi (Sciatica)
3) Patients irrespective of genders will be selected |
|
| ExclusionCriteria |
| Details |
1) osteoarthritis of spine, Spondylolithesis, Ankylosing spondylitis
2) Potts spine
3) Patient having age group less than 30 years and greater than 60 years
4) Pregnant women and Lactating mothers |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Ruka (Pain)
Toda (Pricking sensation) Lakshanas will be decreased |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stambha (Stiffness)
Spandana (Twitching)
Gaurav (Heaviness) this Lakshanas will be decreased |
28 days |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/06/2025 |
| 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 Applicable |
| 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
|
Grudhrasi is charaterized by Ruka, Toda, Spandana, Stambha, along Sphik, Prushta, Kati, Uru Jangha, Pada. Usually the symptoms develops gradually. When Kapha gets associated with Vata the patients experiences Tandra, Gaurava, Aruchi, beside the cardinal features of Grudhrasi. Clinically there is similarity in sign and symptoms of Grudhrasi and Sciatica Hence Grudhrasi can be correlated with Sciatica
The sciatic nerve is the longest and thickest nerve in the human body . It originates from the vertebral column at the level of 4th Lumbar to 3rd Sacral vertebrae and extend up to the feet hence the pain in the sciatica is felt in the lower back and radiates along the nerve up to the feet
In the Ayurveda Grudhrasi is considered as one of the most important Vata Vyadhi and patients facing lost of problems to manage this disease. Srotodusti lakshana and etiopathogenesis of Grudhrasi observe and explained so as to correct the srotodusti by Vishwadi Guggulu and its samprapti bhangatmak chikitsa
The Vishwadi Guggulu is advice in the Bharat Bhaisajya Ratnakar which is Vata and Kapha shamak. The management of patients at OPD level with cheap and effective remedies which should not hamper the daily routine of the patient. Therefore study is undertaken to evaluate the effect of Vishwadi Guggulu in the management of Grudhrasi |