| CTRI Number |
CTRI/2025/02/080402 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Gridhrasi through ayurveda |
|
Scientific Title of Study
|
A CLINICO-COMPARATIVE STUDY TO EVALUTE THE
EFFICACY OF RASNA DASHMOOLA KWATH GHAN VATI AND
SHATARVARYADI DWADASHNAGA KWATH GHAN VATI ALONG
WITH VAAJI GANDHADYA TAILA MATRA BASTI IN THE
MANAGEMENT OF GRIDHRASI W.S.R. 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 Aarti Manjhi |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda
College and Institute Bhopal MP
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
08770763050 |
| Fax |
|
| Email |
dr.artimanjhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Sharma |
| Designation |
Lecturer |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda
College and Institute Bhopal MP
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
9827937247 |
| Fax |
|
| Email |
drvivek.sharma13@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarti Manjhi |
| Designation |
MD Scholar |
| Affiliation |
Pt Khushilal Sharma Govt Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt Khushilal Sharma Govt Ayurveda
College and Institute Bhopal MP
Bhopal
MADHYA PRADESH
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8770763050 |
| Fax |
|
| Email |
dr.artimanjhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Government Autonomous Ayurveda College And Institute, Bhopal (M.P.)
pin code 462003, india |
|
|
Primary Sponsor
|
| Name |
Pt Khushilal Sharma Government Autonomous Ayurveda College and Institute Bhopal MP |
| Address |
PG Department of Kayachikitsa Pt. Khushilal Sharma Government
College and Institute Bhopal MP, 462003, india |
| Type of Sponsor |
Government funding agency |
|
|
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 Aarti Manjhi |
Pt. Khushilal Sharma Government Ayurveda Hospital Bhopal MP |
Room No. 221 PG
Department of
Kayachikitsa Pt.
Khushilal Sharma
Government
(Autonomous)
Ayurveda College and
Institute Bhopal MP
Bhopal
MADHYA PRADESH |
08770763050
dr.artimanjhi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pt Khushilal Sharma Govt Ayurveda College & Institute Bhopal MP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G55||Nerve root and plexus compressionsin diseases classified elsewhere. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: basant c patil, Procedure details: 20 patients of this group will be treated with Rasna Dashmoola
kwath ghanavati along with Matra basti (Vaaji Gandhadya taila))
(1) Medicine Name: Vaaji Gandhadya taila, Reference: gadanigraha, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 21 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasna Dashmoola kwath ghanavati, Reference: vangsena, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi Dvaadashaang kwath ghanavati, Reference: gadanigraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 4 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: basant c patil, Procedure details: 20 patients of this group will be treated with Rasna Dashmoola kwath ghanavati along with Matra basti (Vaaji Gandhadya taila)))
(1) Medicine Name: Vaaji Gandhadya taila, Reference: gadanigraha, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 21 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 20-60 years
2. Sex- either sex
3. Duration of illness- upto 2 years
4. Radiating pain starting from the gluteal region towards the foot
5. Tenderness over the sciatic nerve course
6. Severe pain on squatting
7. Sensory changes
8. Non-involvement of urinary bladder and rectum
9. Positive straight leg raising sign |
|
| ExclusionCriteria |
| Details |
1. Age below 20 years and above 60 years
2. Duration of disease more than 2 years
3. Monoplegia, Paraplegia, Hip joint arthritis, T.B. spine/ Hip
4. Pelvic pathology
5. Traumatic lesion in lumbo-sacral region |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that at the end of study we would be able to demonstrate the
efficacy of Rasna Dashmoola kwath ghanvati and Shatavaryadi
Dvaadashaang kwath ghan vati along with vaajigandhdya tail Matra Basti
in the management of Gridhrasi |
12month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/03/2025 |
| 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="0"
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
|
It is expected that at the end of study we would be able to demonstrate the efficacy of Rasna Dashmoola kwath ghanvati and Shatavaryadi Dvaadashaang kwath ghan vati along with vaajigandhdya tail Matra Basti in the management of Gridhrasi |