| CTRI Number |
CTRI/2024/05/067332 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Clinical Study of 2 Drug Vatnashini Vati and Rasnadi Guggul in the treatment of Gridhrasi W.S.R. to Sciatica. |
|
Scientific Title of Study
|
An Open Randomized Comparative Clinical Study of Vatanadhini Vati (Rasachintamani) With Rasnadi Guggul (Yogaratnakar) 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 |
Umesh Baburao Rathod |
| Designation |
Post Graduate Scholar |
| Affiliation |
APMS Ayurved Mahavidyalay,Sion,Mumbai |
| Address |
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion East, Mumbai
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion East, Mumbai.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9763350331 |
| Fax |
|
| Email |
drumeshrathod07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Rao |
| Designation |
Associate Professor |
| Affiliation |
APMS Ayurved Mahavidyalay,Mumbai |
| Address |
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion East, Mumbai
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion East, Mumbai.
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820725950 |
| Fax |
|
| Email |
vidya.rao163@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Umesh Baburao Rathod |
| Designation |
Post Graduate Scholar |
| Affiliation |
APMS Ayurved Mahavidyalay,Sion,Mumbai |
| Address |
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion East, Mumbai
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Near Sion Station, Sion East, Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9763350331 |
| Fax |
|
| Email |
drumeshrathod07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apms Ayurved Mahavidyalaya and Seth R.V. Ayurvedic Hospital, Near Sion Station, Sion East, Mumbai 400022. |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [] |
|
|
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 Umesh Baburao Rathod |
Seth R.V. Ayurvedic Hospital,Sion |
Department of Kayachikitsa, APMs Ayurved Mahavidyalaya, Seth R.V. Ayurvedic Hospital, Near Sion Railway station,sion,Mumbai-400022
Mumbai
MAHARASHTRA |
9763350331
drumeshrathod07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMs Ayurved Mahavidyalaya Sion |
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: Vatanashini Vati, Reference: Rasachintamani Stabak 9, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -koshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadi Guggula , Reference: Yogratnakar Vatavyadhi chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Patients having pratyatmalakshana of Gridhrasi
Patients having positive SLR test
Tenderness along the course of sciatic nerve |
|
| ExclusionCriteria |
| Details |
1. In secondary Complication- Tuberculosis of the vertebral column.
2. Spinal deformity, spinal tumors, severe traumatic injury, Carcinoma of spine
3. Patient of Gridhrasi involving any structural deformities and needs surgical
care/intervention will excluded.
4. Pregnant women and lactating mothers.
5. Uncontrolled diabetes mellitus, cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Straight leg raise test (in
degree)
|
Baseline, 7th, 14th, 21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the following symptoms along the sciatic nerve route in Mild Moderate & Severe scale
Pain
Pricking sensation
Stiffness
Twitching
|
Baseline, 7th, 14th, 21st & 28th day. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drumeshrathod07@gmail.com].
- For how long will this data be available start date provided 01-08-2026 and end date provided 30-06-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Gridhrasi, an entity enumerated by shula pradhana, is one among the 80 types of Nanatmaja vata
vyadhi. According to Aacharya Charak – Stambha ,Ruka, Toda, and Spandana are the signs and
symptoms of Vataja Gridhrasi. Aruchi, Tandra and Gaurava are additional symptoms of Vata-
Kaphaja Gridhrasi. Gridhrasi nidana are general vata prakopak nidana, in the pathogenesis of
Gridhrasi, Vyana vata plays a major role get masked by Kapha, produces restricted movements as
Gati of Vayu is disturbed. In this disease,
mainly Apana and Vyana Vayu vitiation are observed, but most of the times Kapha remains as
associated Dosha. So for treatment of Gridhrasi, drug of choice should have Vatashamak,
Kaphashamak, Vatanulomaka, Dipana-Pachana, and Shulaprashamana properties.
Vatanashini vati is mentioned in Rasachintamani having all above properties. These properties
may easily reverse the pathogenesis of Gridhrasi. Therefore, to evaluate the effect of
Vatanashini vati in the management of Gridhrasi was planned in the present study. |