| CTRI Number |
CTRI/2025/05/087941 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical study to Know the effect of Matra basti with Sapta prastha Mahamashadi Tailam and Vishwadya guggulu in the Treatment of Kampavata wsr to Parkinsons disease |
|
Scientific Title of Study
|
An open labelled non-randomized clinical study to evaluate the effect of Matra Basti with Sapta Prastha Mahamashadi Tailam and Vishwadya Guggulu (oral) in the management of Kampavata w.s.r. to Parkinson’s disease |
| Trial Acronym |
PD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Smeetha Havaragi |
| Designation |
Post Graduate in Kayachikitsa |
| Affiliation |
Dr.BRKR Govt Ayurveda Medical college |
| Address |
Dr.BRKR Govt Ayurveda Medical college,opposite to ESI Hospital AG colony road Sr nagar Erragadda Hyderabad.
Hyderabad
TELANGANA
500018
India |
| Phone |
9900734897 |
| Fax |
|
| Email |
havaragismeeta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Srikanth Babu |
| Designation |
PG Professor and Guide MD Ayurveda Department of Kayachikitsa |
| Affiliation |
Dr.BRKR Govt Ayurveda Medical college |
| Address |
Dr.BRKR Govt Ayurveda Medical college,opposite to ESI Hospital AG colony road Sr nagar Erragadda Hyderabad
Dr.BRKR Govt Ayurveda Medical college,opposite to ESI Hospital AG colony road Sr nagar Erragadda Hyderabad
Hyderabad
TELANGANA
500018
India |
| Phone |
9849463878 |
| Fax |
|
| Email |
drperugu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Srikanth Babu |
| Designation |
PG Professor and Guide MD Ayurveda Department of Kayachikitsa |
| Affiliation |
Dr.BRKR Govt Ayurveda Medical college |
| Address |
Dr.BRKR Govt Ayurveda Medical college,opposite to ESI Hospital AG colony road Sr nagar Erragadda Hyderabad.
Hyderabad
TELANGANA
500018
India |
| Phone |
9849463878 |
| Fax |
|
| Email |
drperugu@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.BRKR GOVT AYURVEDA MEDICAL COLLEGE OPPO TO ESI HOSPITAL AG COLONY ERRAGADDA SR NAGAR HYDERABAD |
|
|
Primary Sponsor
|
| Name |
Dr.Smeetha Havaragi |
| Address |
DR.BRKR GOVT AYURVEDA MEDICAL COLLEGE OPPO TO ESI HOSPITAL AG COLONY ERRAGADDA SR NAGAR HYDERABAD |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSMEETHA HAVARAGI |
DR.BRKR GOVT AYURVEDA MEDICAL COLLEGE OPPO TO ESI HOSPITAL AG COLONY ERRAGADDA SR NAGAR HYDERABAD |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Smeetha Havaragi |
Dr BRKR Government Ayurveda Hospital Eragadda Hyderabad. |
OPD Room NO 1,2,3 Department of Kayachikitsa Dr BRKR Government Ayurveda Hospital Eragadda Hyderabad.
Hyderabad
TELANGANA |
9900734897
havaragismeeta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of Dr.B.R.K.R Government Ayurvedic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Viswadya Guggulu, Reference: Brihath Nigantu Ratnakar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Sukoshna jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: Chakradatta, Procedure details: Patient is lied in left lateral position immediately after food in morning , Then Medicated oil about of 60ml quantity is injected through rectal route for first 7 days for 3 months ( 3 cycles of basti in 90 days ) )
(1) Medicine Name: Sapta Prastha Mahamashadi tailam, Reference: Chakradatta, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient who are having signs and symptoms of Kampavata (Parkinson s Disease)
2 Patients of both Gender aged between 30 to 65 years irrespective of work and socioeconomic status
3 Patients indicated for Basti Karma
4Patients willing to give informed consent for the study
|
|
| ExclusionCriteria |
| Details |
1 Below 30 years and Above 65 years
2 Pregnant and Lactating Mothers
3 Patient having severe heart disease malignancy uncontrolled Diabetes mellitus and Hypertension
4 Patient associated with major Neurological problems like Spinal cord injury Multiple system atrophy CVA (hemorrhage and infarct) Alzheimer s disease
5 Patient contraindicated for Basti karma
6 Patient not willing to give informed consent for the study
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms and Quality of living |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms and Quality of living |
90 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
08/06/2025 |
| 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 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 - 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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [havaragismeeta@gmail.com].
- For how long will this data be available start date provided 08-06-2025 and end date provided 08-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Title of study is An open labelled non-randomized clinical study to evaluate the effect of Matra Basti with Sapta Prastha Mahamashadi Tailam and Vishwadya Guggulu oral in the management of Kampavata wsr to Parkinsons disease 1 Vishwady guggulu 500mg tab BD is given oral route after food for 90 days 2.Matrabasti with Sapta prasatha Mahamashadi tailam is given for first 7 days for 3 months immediately after food in the Morning |