| CTRI Number |
CTRI/2024/08/072874 [Registered on: 22/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Parkinsons disease with Ayurvedic intervention |
|
Scientific Title of Study
|
A clinical study on kampavata with special reference to Parkinsons disease and its management with indigenous drug |
| 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 Neha Tiwari |
| Designation |
PG SCHOLAR |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya Puri |
| Address |
Gopabandhu Ayurveda Mahavidyalaya
Department of Kayachikitsa
VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9337265316 |
| Fax |
|
| Email |
nehatiwaritn97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sudarsan Behera |
| Designation |
Former Principal & Professor MD (Ayu) PhD ( UU) |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Gopabandhu Ayurveda Mahavidyalaya and hospital PG Department of Kayachikitsa VIP Road Puri Odisha 752002
Puri
ORISSA
752002
India |
| Phone |
9437199477 |
| Fax |
|
| Email |
drsudarsanb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Sudarsan Behera |
| Designation |
Former Principal and Professor MD(Ayu) Ph.D(U.U) |
| Affiliation |
Gopabandhu Ayurveda Mahavidyalaya VIP Road Puri |
| Address |
Gopabandhu Ayurveda Mahavidyalaya PG Department of Kayachikitsa VIP Road Puri
Puri
ORISSA
752002
India |
| Phone |
9437199477 |
| Fax |
|
| Email |
drsudarsanb@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD AND IPD OF PG DEPARTMENT OF KAYACHIKITSA GOPABANDHU AYURVEDA MAHAVIDYALAYA VIP ROAD PURI ODISHA 752002 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Tiwari |
| Address |
PG DEPARTMENT OF KAYACHIKITSA GOPABANDHU AYURVEDA MAHAVIDYALAYA
VIP ROAD PURI 752002 |
| 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 Neha Tiwari |
Gopabandhu Ayurveda Mahavidyalaya And Hospital |
OPD AND IPD OF PG DEPARTMENT OF KAYACHIKITSA
GOPABANDHU AYURVEDA MAHAVIDYALAYA
VIP ROAD PURI ODISHA 752002
Puri
ORISSA |
9337265316
nehatiwaritn97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Gopabandhu Ayurveda Mahavidyalaya and Hospital Puri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G318||Other specified degenerative diseases of nervous system. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | LEVODOPA | LEVODOPA 200 mg is advised twice daily after food
Duration 90 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: INDIGENOUS DRUG, Reference: BHAVAPRAKASH NIGHANTU, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -LUKE WARM WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patient having the clinical sign and symptoms of Parkinsons disease |
|
| ExclusionCriteria |
| Details |
Patient aged below 18years and above 80years
Patient having heart diseases
Malignancies
Hypothyroidism
Uncontrolled Hypertension and Diabetes Mellitus
Cerebrovascular accidents
Alzheimers disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prevent signs and symptoms of Parkinsons disease in patients |
3months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce tremor rigidity bradykinesia postural disturbance in patients |
3months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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="3"
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
|
This study a single blind randomized controlled trial of 3 months duration to compare efficacy of indigenous drug and levodopa in patients suffering from Kampavata with special reference to Parkinsons disease. The primary outcome is to prevent Parkinsons disease in patients and secondary outcome is to reduce tremor rigidity bradykinesia and postural disturbance in patients. |