| CTRI Number |
CTRI/2025/08/092644 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluating the Benefits of Two Ayurvedic Vasti Treatments in Stroke Recovery: A Comparison of Granthikadi Taila and Mahamasha Taila with Erandamooladi Niruha Vasti in Patients with Paralysis (Pakshaghata) After Thrombotic Stroke"
|
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Scientific Title of Study
|
Evaluation of comparative efficacy of Granthikadi Taila Anuvasana Vasti versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) in both groups in the management of Thrombotic Stroke (Pakshaghata): A Randomized Controlled Trial |
| 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 Ram Prakash Verma |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurvedic College Hospital and Research Centre |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
8517056187 |
| Fax |
|
| Email |
ramprakashv78@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ram Prakash Verma |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurvedic College Hospital and Research Centre |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod
MAHARASHTRA
442001
India |
| Phone |
8517056187 |
| Fax |
|
| Email |
ramprakashv78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Ade |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurvedic College Hospital and Research Centre |
| Address |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurveda College Hospital and Research Centre Hirapur Salod
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Hirapur Salod Wardha, Maharashtra, India ,442001 |
|
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Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
| Address |
Room no 40 Department of Panchkarma Mahatma Gandhi Ayurved College Hospital
and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India |
| 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 Ram Prakash Verma |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
OPD no 40 Department of Panchkarma Mahatma Gandhi Ayurved College Hospital
and Research Centre Hirapur Salod Wardha MAHARASHTRA 442001 India
Wardha
MAHARASHTRA |
8517056187
ramprakashv78@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G819||Hemiplegia, unspecified. Ayurveda Condition: PAKSHAGHATA/PAKSHAVADHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sushruta Chikitsasthana 5/19, Procedure details: Granthikadi Taila Anuvasana Vasti and Erandamooladi Niruha Vasti will be administered alternately in the Yoga Vasti pattern to the patient for 8 days. Follow-up of the patient will be done on the 0th, 8th, and 24th day.)
(1) Medicine Name: Granthikadi Taila Anuvasana Vasti, Reference: Vangsena 60/212, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Erandamooladi Niruha Vasti , Reference: charak siddhisthana 3/38-42, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 3 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sushrut Chikitsa 5/19, Procedure details: Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti will be administered alternately in the Yoga Vasti pattern to the patient for 8 days. Follow-up of the patient will be done on the 0th, 8th, and 24th days))
(1) Medicine Name: Mahamasha Taila Anuvasana Vasti, Reference: Bhaishajya Ratnavali Vatavyadhi adhikar 241-245, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Erandamooladi Niruha Vasti, Reference: charak siddhisthana 3/38-42, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 960(ml), Frequency: od, Duration: 3 Days |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to provide written informed consent and abide by the instructions
Patients with Thrombotic Stroke (Pakshaghata) recently diagnosed through MRI brain [15 days to 6 months]
Patients with Thrombotic Stroke (Pakshaghata) of either gender aged between 21-70 years
Patients fit for Anuvasana Vasti and Niruha Vasti
|
|
| ExclusionCriteria |
| Details |
Patients having Cardiac Disease like AMI, Angina, etc
Patients having DM - Neuropathy, Retinopathy
Pregnant and Lactating women
Patient with Acute complications like Cirrhosis of the liver, Pancreatitis, and Hypoglycemic shock
Patient with haemorrhagic stroke
Patients with known brain space-occupying lesions such as tumors, abscesses, or cysts
Patients having unControl Hypertension [Systolic BP more than 140 and Diastolic BP more than or equal to 90 mmHg] and unControl Diabetes Mellitus[FBS more than 130mg per dl ,PPBS more than 180 mg per dl]
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Granthikadi Taila Anuvasana Vasti and Erandamooladi Niruha Vasti Versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) through Dynamic Gait Index, Berg Balance Scale, Barthel Index and NIHSS in patients with Thrombotic Stroke (Pakshaghata) |
at baseline
8 days
24 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and assessment of Granthikadi Taila Anuvasana Vasti and Erandamooladi Niruha Vasti Versus Mahamasha Taila Anuvasana Vasti and Erandamooladi Niruha Vasti (Yoga Vasti) through Dynamic Gait Index Berg Balance Scale Barthel Index and NIHSS in patients with Thrombotic Stroke (Pakshaghata) |
at baseline
1 week 1day
3 week3days |
|
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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)
|
07/09/2025 |
| 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="2"
Months="0"
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 - NO
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Brief Summary
|
The volunteers will be informed about the study protocol. Willing participants will be randomly
selected as per computer generated table. Clinical research format will be prepared and validated.
Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI
registration will be done. After selection, each participant will be tested individually and
selected according to selection criteria. They are divided into two groups the trial is a Randomized
open labelled Standard controlled equivalence clinical trial. It will include a 8 days treatment
period and a follow up period of 0th, 8th and 24th day. |