| CTRI Number |
CTRI/2025/02/081290 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Basti karma] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate Effectiveness of Mahamasha taila matra basti and mashabaladi kwatha in stroke |
|
Scientific Title of Study
|
An open label single arm clinical study on the combined effectiveness of mahamasha taila matra basti and mashabaladi kwatha in the management of pakshaghata(cerebrovascular accident-infarct) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSharath |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital b m road thanniruhalla , hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9731825452 |
| Fax |
|
| Email |
sharathmethre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrLakshmiprasad L Jadhav |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital b m road thanniruhalla , hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886614116 |
| Fax |
|
| Email |
drjadhav@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
DrLakshmiprasad L Jadhav |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital hassan |
| Address |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital b m road thanniruhalla , hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886614116 |
| Fax |
|
| Email |
drjadhav@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital b m road thanniruhalla , hassan 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SDM COLLEGE OF AYURVEDA HOSPITAL TANNERHALLA BM ROAD HASSAN KARNATAKA INDIA |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSharath |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital hassan |
Department of Kayachikitsa Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital b m road thanniruhalla , hassan 573201
Hassan
KARNATAKA |
9731825452
sharathmethre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Bhaishajya Ratnavali, Procedure details: abhaynga followed by nadisweda
Matrabasti 0F 72ml administered for a duration of 8days)
(1) Medicine Name: Mashabaladi Kwatha , Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 15(ml), Frequency: tds, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Glasgow coma scale more than 8
2. subjects fit for basti karma
3. subjects who are ready to participate and sign the informed consent form |
|
| ExclusionCriteria |
| Details |
1. Diagnosed case of intracranial hemorrhage,intracranial space occupying lesion,congenital defects,carcinoma,intracranial infections and retriviral diseases
2. marked impaired mental functions
3. subjects with uncontrolled diabetese mellitus[HbA1c more than 8mg/dl] and uncontrolled hypertension[more than 160/100mmhg]
4. pregnant women
5. lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be based on the symptoms
chesta nivritti
vakstambha
ruja |
1st day, 9th day and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
National institute of health[NIH] stroke scale
Medical research council[MRC] scale of muscle strength |
1st day,9th day and 31st day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The study title is An Open label single arm Clinical study on the combined effectiveness of mahamasha taila matra basti and mashabaladi kwatha in the management of pakshaghata [cerebrovascular accident-infarct] which involves total of 30 participants in the study, which includes age from 30 to 65 years and glasgow coma scale more than 8,and study excludes uncontrolled diabetes mellitus and uncontrolled hypertension and pregnant women, and assessment will be done on 1st,9th and 31st day after the procedure and results of the following study will be analyzed and calculated by using the SPSS and other suitable statistical software. |