| CTRI Number |
CTRI/2025/01/078909 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs, Erandadi Kwatha and Simhasyadi Kwatha in the treatment of Sciatica |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Erandadi Kwatha and Simhasyadi Kwatha in 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 |
Dr Chahat Rastogi |
| Designation |
PG Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre Gangoh |
| Address |
Department of Kaya Chikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobit University, Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8383088718 |
| Fax |
|
| Email |
chahatrastogi1826@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chahat Rastogi |
| Designation |
Pg Scholar |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre Gangoh |
| Address |
Department Of Kaya Chikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College and Research Centre Shobit University, Gangoh
UTTAR PRADESH
247341
India |
| Phone |
8383088718 |
| Fax |
|
| Email |
chahatrastogi1826@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AP SINGH |
| Designation |
Professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre Gangoh |
| Address |
Department Of Kaya Chikitsa Of Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre, Gangoh
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9410088322 |
| Fax |
|
| Email |
apsingh11264@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar shekhar vijendra ayurved medical college and research centre shobit university, gangoh Saharanpur, Uttar pradesh-247341 |
|
|
Primary Sponsor
|
| Name |
kunwar Shekhar Vijendra Ayurved Medical College And Research Centre Shobit University, Gangoh |
| Address |
Adarsh Babu Vijendra Marg Institutional Area, Gangoh, Saharanpur, Uttar Pradesh-247341 |
| 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 Chahat Rastogi |
KUNWAR SHEKHAR VIJENDRA AYURVED MEDICAL COLLEGE & RESEARCH CENTRE GANGOH |
Department of kaya chikitsa
Saharanpur
UTTAR PRADESH |
8383088718
chahatrastogi1826@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kunwar Shekhar Vijendra Ayurved Medical College & Research Centre Gangoh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: VATAKAPAJA-GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Erandadi Kwatha, Reference: Bhavaprakash Chapter28 shlok no138, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhasyadi Kwatha, Reference: Bhavaprakasha Chapter28 shlok no140, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject of age group between 20 to 70 years and irrespective
of caste, sex, religion, occupation and socio – economic status.
2. Subject presented with signs & symptoms of Gridhrasi (Sciatica).
3. Subject willing to give informed consent to participate for 45 days.
|
|
| ExclusionCriteria |
| Details |
1. Gridhrasi roga more than 10 years old.
2. T.B spine, Tumors of spinal cord, Malignancy of pelvis.
3. Diabetic neuropathy, Cauda-equina syndrome.
4. Subjects who are pregnant and lactating.
5. Subjects had completed participation in any other clinical trial in past 6
months.
6. Subjects who have sciatica caused due to injury, accidents, trauma etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in sign & symptoms of sciatica |
45days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cost effective treatment
To observe if there any adverse effect |
45days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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
|
The volunteer will be informed about the study protocol . Willing participant will be randomly selected as per computer generated table. The clinical research format will be validated . Single Centre, Open labelled, Randomized, Interventional Study. Comparing the safety and efficacy of Erandadi Kwatha and Simhasya Kwatha in Gridhrasi . Subjects are selected randomly computerised method on the basis of inclusion criteria. Drugs are given to subjects in parallel group of 70 patients.
|