| CTRI Number |
CTRI/2025/02/080704 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of bahirparimarjana,anuvasana basti followed by shamanoushadhi in the management of kampavata(parkinsons disease) |
|
Scientific Title of Study
|
An open label randomized comparative clinical study to evaluate the efficacy of bahirparimarjana anuvasana basti followed by shamanoushadhi in the management of kampavata vis-a-vis parkinsons disease |
| 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 Pooja |
| Designation |
Pg scholar |
| Affiliation |
Jss ayurveda medical college and Hospital |
| Address |
Jss ayurveda medical college and hospital kayachikitsa OPD no 1 41 E Lalithadripura Road Alanahalli Mysuru Karnataka 570028 India
Mysore
KARNATAKA
570028
India |
| Phone |
9902547040 |
| Fax |
|
| Email |
rasurpooja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa C Patil |
| Designation |
Professor |
| Affiliation |
Jss ayurveda medical college and Hospital |
| Address |
Jss ayurveda medical college and hospital kayachikitsa OPD no 1 41 E Lalithadripura Road Alanahalli Mysuru Karnataka 570028 India
Mysore
KARNATAKA
570028
India |
| Phone |
9886485005 |
| Fax |
|
| Email |
deepsmysore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja |
| Designation |
Pg scholar |
| Affiliation |
|
| Address |
Jss ayurveda medical college and hospital kayachikitsa OPD no 1 41 E Lalithadripura Road Alanahalli Mysuru Karnataka 570028 India
Mysore
KARNATAKA
570028
India |
| Phone |
9902547040 |
| Fax |
|
| Email |
rasurpooja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jss ayurveda medical college and hospital kayachikitsa OPD no 1 41 E Lalithadripura Road Alanahalli Mysuru Karnataka 570028 India |
|
|
Primary Sponsor
|
| Name |
Dr Pooja |
| Address |
Jss Ayurveda Medical College And Hospital Mysore 41/E Lalithadripura Road Alanahalli Mysuru Karnataka 570028
2/224, Near Gram Panchayat, Mannaekhalli, Mannaekhakki, Bidar Karnataka,585227 |
| Type of Sponsor |
Other [self] |
|
|
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 Pooja |
Jss ayurveda medical college and hospital |
Jss ayurveda medical college and hospital kayachikitsa OPD no 1 41 E Lalithadripura Road Alanahalli Mysuru Karnataka 570028 India
Mysore
KARNATAKA |
09902547040
rasurpooja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Koushikokta rasnadi kwatha, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saramayanataka Ghrita , Reference: Sahasrayogam, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Subjects exhibiting kampa stambha gatisanga as a cardinal features
subjects who are under medication of parkinsons disease
|
|
| ExclusionCriteria |
| Details |
Subjects diagnosed with other neurodegenerative disorders like alzheimer’s disease diabetic autonomic neuropathy and other which interfere with the course of treatment
Subjects with other systemic Disorders which interfere with the course of treatment
Subjects diagnosed with psychiatric diseases such as schizophrenia and bipolar mood disorder
Subjects diagnosed with brain tumour
Subjects who are unfit for basti karma will be excluded
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the Combined effect of Bahirparimarjana,Anuvasana Basti followed by Shamanoushadhi in the management of kampavata vis-a-vis Parkinsons Disease
|
To Compare the Combined effect of Bahirparimarjana,Anuvasana Basti followed by Shamanoushadhi in the management of kampavata vis-a-vis Parkinsons Disease |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO EVALUATE THE EFFICACY OF BAHIRPARIMARJANA, ANUVASANA BASTI FOLLOWED BY KOUSHIKOKTA RASANADI KWATHA IN THE MANAGEMENT OF KAMPAVATA VIS-A-VIS PARKINSONS DISEASE
TO EVALUATE THE EFFICACY OF BAHIRPARIMARJANA, ANUVASANA BASTI FOLLOWED BY SARVAMAYANTAKA GHRITA IN THE MANAGEMENT OF KAMPAVATA VIS-A-VIS PARKINSONS DISEASE |
Before Treatment 0th day
After Bahirparimarjana & Anuvasana Basti 10th day
After Shamanoushadi 41st day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| Date of Study Completion (India) |
08/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
08/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Parkinson’s disease(PD) is the second most common age- related Neurodegenerative disease. Clinically it is characterized by tremor, rigidity, bradykinesia, speech difficulty, swallowing impairment, gait dysfunction with postural instability, and series of non-motor features that include autonomic disturbances, sensory alterations, mood disorders, sleep dysfunction, cognitive impairment, and dementia. In Kampavata increased Chala Guna of Vata produces Kampa where as increased Manda Guna of Kapha produces Chestasanga. This Kaphavrutta Vyana Vata needs Ruksha and Snigdha Chikitsa alternatively Hence in this study management of Kampavata is planned as follows: Ruksha Ushna Chikitsa with Churna Pinda Sweda, Snigdha Ushna Chikitsa with Sarvanga Abhyanga Nadi Sweda And Anuvasana Basti with Astadashanga Masha Taila followed by Shamanaushadhi’s - Koushikokta Rasnadi Kwatha9 and Sarvamayantaka Ghrita10 which are directly indicated in Kampavata
|