| CTRI Number |
CTRI/2025/10/095693 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the Effectiveness of Panchkarma on Patients with Parkinson’s Disease: A Clinical Trial |
|
Scientific Title of Study
|
Evaluate The Efficacy of Panchkarma Protocol in The Management of Kampavata (Parkinson’s Disease) An Open Labelled Randomized Controlled Clinical 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 Ajay Kumar Yadav |
| Designation |
Ph.D. Scholar |
| Affiliation |
National Institute of Ayurveda, (DU), Jaipur. |
| Address |
Room number 111, First Floor, Department of Panchkarma, National Institute of Ayurveda (DU), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9680950001 |
| Fax |
|
| Email |
ajayyadav21893@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Professor and Head of Department |
| Affiliation |
National Institute of Ayurveda, (DU), Jaipur. |
| Address |
Room number 114, First Floor, Department of Panchkarma, National Institute of Ayurveda (DU), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gopesh.pk@nia.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umakant Gupta |
| Designation |
Consultant Physician |
| Affiliation |
National Institute of Ayurveda, (DU), Jaipur. |
| Address |
Room number 01, Ground Floor, Hospital block, National Institute of Ayurveda (DU), Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9829077318 |
| Fax |
|
| Email |
dr_ukgupta@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda (Deemed University), Jaipur, Rajasthan, Bharat. 302002. |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda (Deemed University) |
| Address |
Jorawar Singh Gate, Amer Road, Jaipur. |
| Type of Sponsor |
Government 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 Ajay kumar yadav |
National Institute of Ayurveda (DeemedUniversity) |
Panchkarma Department, OPD Number 2, Main Hospital Building, Jorawar Singh Gate, Amer Road, Jaipur.
Jaipur
RAJASTHAN |
9680950001
ajayyadav21893@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
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 | Comparator Arm (Non Ayurveda) | | - | Levodopa Carbidopa Combination | The Control Group involves administering a combination of Levodopa (100 mg) and Carbidopa (25 mg) orally, at a dose of one tablet twice daily, with the possibility of dose escalation depending on the severity of the disease. The total duration of treatment will be 75 days, followed by a 30-day post-treatment follow-up period. | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Vangasena vol. I 28/155, Procedure details: The patients will initially undergo Deepana–Pachana with Shunthi-Dhanyaka Yavakuta, administered as Panaka in a dose of 5 g each throughout the day for 3 to 5 days. This will be followed by Udvartana with Triphala and Yava Churna in a quantity of 1 to 1.5 kg for 3 to 5 days.
For Virechana Karma, Snehapana will be performed with cow’s ghee in a total dose of 400–600 ml over 03-07 days, accompanied by Abhyanga with Dashmoola Taila (100–150 ml) and Swedana. The Virechana will then be carried out using Trivrut Churna in a dose of 10–15 g.
The Basti Karma will consist of Anuvasana Basti with Masha Taila 150 ml, administered in the morning between 9–11am after light food, and Niruha Basti prepared with Madhu (120 ml), Saindhava (7 g), Tila Taila (180 ml), Shatapuspadi Kalka (50 g), Masha Kwatha (240 ml), and Ksheera (240 ml), making approximately 600 ml in total, administered in the morning between 8–11 am on an empty stomach. This Basti procedure will be continued for 18 days.
Additionally, Shirobasti will be performed with Masha Taila in a dose of 1000 ml, administered in the evening between 3–6 pm, for 7 days. Finally, Snehapana with Masha Taila will be given in a dose of 25 ml, taken with milk in the morning on an empty stomach, for the next 30 days.
)
(1) Medicine Name: Masha Taila, Reference: Chakradutta 22/157-161, Route: Oral, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinical signs and symptoms of Kampavata(Parkinson’s Disease).
2. Controlled diabetes and hypertension cases to be taken with conventional medicine.
3. Preferably freshly diagnosed cases as well as cases of Kampavata(Parkinson’s Disease) with a chronicity of less than 10 years with persisting symptoms despite allopathy medications.
4. Patients willing to participate for an interventional study. |
|
| ExclusionCriteria |
| Details |
Patients unfit for Virechana, Basti and Shirobasti. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Serum Dopamine level. |
Day 0 (Baseline), After 75 Days of Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in UPDRS score
2. Changes in symptoms like Kampa, Chestasanga (Akinesia and Bradykinesia), Stambha, Avanamana, Vakvikruti and Gatisanga.(As per Assessment Scale mentioned in CRF)
|
Day 0 (Baseline), Day 75, and Day 105(Follow-up) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/10/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This clinical trial is designed to evaluate the efficacy of
a Panchakarma protocol—comprising Virechana, Karma Basti, and Shirobasti
followed by Brihmana Snehapana with Masha Taila—in the management of Kampavata
(Parkinson’s Disease). The study is an open-label, randomized, controlled,
double-arm interventional trial to be conducted at the Department of
Panchakarma, National Institute of Ayurveda, Jaipur. A total of 70 patients
aged 30–70 years with clinical features of Kampavata, including bradykinesia,
tremors, rigidity, postural changes, and gait disturbances, will be enrolled.
Patients will be randomly allocated into two groups: Group A receiving
Panchakarma protocol with Masha Taila-based interventions, and Group B
receiving standard control (Levodopa-Carbidopa therapy). The intervention will
be carried out over 75 days with a 30-day follow-up. Primary outcome measures
include changes in serum dopamine levels, while secondary outcomes include
improvements in Unified Parkinson’s Disease Rating Scale (UPDRS), symptom severity
(Kampa, Stambha, Chestasanga, Vakvikriti, Avanamana, Gatisanga), and quality of
life (PDQ-8). Statistical analysis will be performed using both parametric and
non-parametric methods, with significance set at p<0.05. The trial aims to
establish whether Panchakarma therapy provides superior clinical benefits
compared to standard therapy in Parkinson’s disease.
|