| CTRI Number |
CTRI/2024/08/072140 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of Mustadi Yapana basti in patients of Pakshaghata w.s.r to hemiplegia associated with and without co-morbidities. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Mustadi yapana basti in Pakshaghata with and without co-morbidities. |
| 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 Sudhehi V Acharya |
| Designation |
Post Graduate Student |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi |
| Address |
Department of Panchakarma, Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Kuthpady, Udupi, Karnataka.
Udupi
KARNATAKA
574118
India |
| Phone |
7975669685 |
| Fax |
|
| Email |
sudhehi31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Niranjan Rao |
| Designation |
Professor and HOD of Department of Panchakarma |
| Affiliation |
Shri Dharmasthala Manjuntheshwara college of Ayurveda and Hospital, Udupi |
| Address |
Department of Panchakarma, Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Kuthpady, Udupi, Karnataka.
Udupi
KARNATAKA
574118
India |
| Phone |
9448835203 |
| Fax |
|
| Email |
rao.drniranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Niranjan Rao |
| Designation |
Professor and HOD of Department of Panchakarma |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi |
| Address |
Department of Panchakarma, Shri Dharmasthala Manjunatheshwara College of Ayurveda and hospital, Kuthpady, Udupi, Karnataka.
Udupi
KARNATAKA
574118
India |
| Phone |
9448835203 |
| Fax |
|
| Email |
rao.drniranjan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Kuthpady, Udupi, Karnataka, India.
Pincode - 574118 |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Kuthpady, Udupi, Karnataka, India.
Pincode - 574118 |
| Type of Sponsor |
Private medical college |
|
|
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 Sudhehi V Acharya |
Shri Dharmasthala Manjuntheshwara college of Ayurveda and Hospital, Udupi |
Department of Panchakarma, Shri Dharmasthala Manjuntheshwara college of Ayurveda, Kuthpady, Udupi, Karnataka, India.
Pincode - 574118
Udupi
KARNATAKA |
7975669685
sudhehi31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee - human |
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 | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charaka Samhita, Procedure details: Group 2 - Pakshaghata associated with co-morbidities like Hypertension, Diabetes mellitus. Mustadi yapana basti will be administered in dose of 480 ml in Yoga basti course, where three basti will be administered on 2nd, 4th and 6th day of treatment course. Anuvasana basti with Murchita tila taila in dose of 60 ml will be administered on 1st, 3rd, 5th, 7th day.)
| | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charaka Samhita, Procedure details: Group 1 - Pakshaghata without co-morbidities. Mustadi yapana basti will be administered in dose of 480 ml in Yoga basti course, where three basti will be administered on 2nd, 4th and 6th day of treatment course. Anuvasana basti with Murchita tila taila in dose of 60 ml will be administered on 1st, 3rd, 5th, 7th day.)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
•Patients fulfilling the diagnostic criteria of pakshaghata.
•Patients in the age group of 18-70 years.
•Patients fit for Niruha basti.
|
|
| ExclusionCriteria |
| Details |
•Patients with hemiplegia due to causes like intracranial infections, space occupying lesions, malignancy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in muscle power, muscle tone. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in all other symptoms of pakshaghata |
21 days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/08/2024 |
| 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="0"
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 current study will be a comparative clinical study to evaluate the effect of mustadi yapana basti in a minimum of 30 diagnosed case of pakshaghata which will be allotted into with and without co-morbidity groups with 15 patients in each and to study the effects of mustadi yapana basti on associated co-morbidities like hypertension and type 2 diabetes mellitus. |