| CTRI Number |
CTRI/2024/02/063363 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To check the efficacy OF Grudhrasi Kwath in Grudhrasi Sciatica |
|
Scientific Title of Study
|
Assesment of Grudhrasi Kwath in the Treatment of Grudhrasi 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 |
Dr Vitrag Shrenik Doshi |
| Designation |
PG Scholar |
| Affiliation |
Bharti Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Bharti Vidyapeeth Deemed to be University College of Ayurved Department of Kayachikitsa Katraj Dhankawadi Campus Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9130259000 |
| Fax |
|
| Email |
vitrag.doshi-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dattatraya L Shinde |
| Designation |
Professor |
| Affiliation |
Bharti Vidyapeeth Deemed to be University College of Ayurveda Pune |
| Address |
Bharti Vidyapeeth Deemed to be University College of Ayurved Department of Kayachikitsa Katraj Dhankawadi Campus Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde249@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatraya L Shinde |
| Designation |
Professor |
| Affiliation |
Bharti Vidyapeeth Deemed to be University College of Ayurveda Pune |
| Address |
Bharti Vidyapeeth Deemed to be University College of Ayurved Department of Kayachikitsa Katraj Dhankawadi Campus Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde249@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth deemed to be university College of Ayurved and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Vitrag S Doshi |
| Address |
Bharati Vidyapeeth Deemed To Be University College Of Ayurved Katraj Dhankawadi Campus Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Vitrag S Doshi |
Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital |
Department of Kaychikitsa
Second floor, passage Area
Room No- 1,Room Name-Head of Department ( Dr.Dattatray.L.Shinde M.D PhD Professor Dept of Kaychikitsa pune Maharashtra
Pune
MAHARASHTRA |
9130259000
vitrag.doshi-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University Pune India College of Ayurved Pune Satara Road Pune 411043 ETHICS COMMITTEE [BV(DU)COA EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Grudhrasi Kwatha, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Grudhrasi Kwatha will be prepared as mentioned in Sharangadhara Samhita Madhyam Khanda. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of age between 18-70 years of both Gender.
2 Patients with presence of Ruk(pain), Toda (Pricking Pain), Stambha (Stiffness), and Spandan (Twitching) in the Spik, Kati (Waist) Uru ,Janu( Knee joint), Jangha (calf muscles) and Pada ( feets)
|
|
| ExclusionCriteria |
| Details |
1 Patients suffering from several traumatic injury,spinal tumor and spinal deformity .
2 Patients of Grudhrasi associated with any of following disorder will be excluded from study such as- Rheumatoid arthritis, auto immune disease.
c)Any other inflammatory disorder like Tubercular Arthritis, Septic Arthritis, Tuberculosis of spine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Straight Raise Test Degrees |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
75% reduction Improvement in SLR Test Improvement in vas scales.
Improvement in Walking time
|
Baseline, 7th,14th,21th,28th and 30th Day follow up. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2024 |
| Date of Study Completion (India) |
28/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Article in process |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study will conducted after obtaining permission from institutional ethical community & will be registered CTRI IndiaAs per inclusion criteria patient will be selected & screening done at OPD Subjective & Objective parameters will be checked & noted. Whole research procedure & Aim will be clearly informed to patients hence Form will be signed by enrolled participants & case report form will be filled. Conduct of trial Patient will be examined in OPD on the first day of visit for sign & symptoms of Grudhrasi with Straight Leg Raise Test. After investigation ( X- Rays Lumbar Spine Anterio-Posterio/Lateral) Patients will be allocated for treatment.pre assesment will be done on 0 days Once patients is enrolled in study protocol Grudhrasi Kwath will be given to patients for 30 days. Follow up will conducted on 7, 14,21,28 day. respectively 30 days will be last chakeup. Patients will be observed & if patients not following treatment protocol or not willing to continue treatment can be considered as a droup out aversion to treatment unwanted effects. If any side effects occurs then proper treatment adviced. On day one- Patients will be observed for Subjective parameters ( sign/ Symptoms) On Day Two- Test drug will be given to patients up to 30 days then asked to Consume as per Standard guidelines given to then on the day Two.
|