| CTRI Number |
CTRI/2025/02/080301 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the Effectiveness of Mashadya Taila Basti (Medicated Enema) and Mashadya Taila Nasya (Nasal Therapy) in the Management of Kampavata (Parkinson’s Disease): A Randomized Clinical Trial |
|
Scientific Title of Study
|
Randomized Clinical Study of Mashadya Taila Basti and Mashadya Tail Nasya in the Management of Kampavata with Reference to Parkinson’s 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 PRANALI SUNILJADHAV |
| Designation |
PG SCHOLAR |
| Affiliation |
Padmashreee Dr D Y Patil School of ayurveda, Nerul, Thane, Navi Mumbai |
| Address |
D Y Patil School of Ayurveda, 1st floor, opd no.1, Dept of Kayachikitsa, D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9665615827 |
| Fax |
|
| Email |
jadhavpranali1412@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Mhatre |
| Designation |
Associate Professor |
| Affiliation |
Padmashreee Dr D Y Patil School of ayurveda, Nerul, Thane, Navi Mumbai |
| Address |
D Y Patil School of Ayurveda, 1st floor, opd no.1, Dept of Kayachikitsa, D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9819639895 |
| Fax |
|
| Email |
ashishmhatre2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Mhatre |
| Designation |
Associate Professor |
| Affiliation |
Padmashreee Dr D Y Patil School of ayurveda, Nerul, Thane, Navi Mumbai |
| Address |
D Y Patil School of Ayurveda, 1st floor, opd no.1, Dept of Kayachikitsa, D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9819639895 |
| Fax |
|
| Email |
ashishmhatre2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil School of Ayurveda and Hospital, D Y Patil Vidyanagar Sector 7 Nerul Navi Mumbai 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Pranali Jadhav |
| Address |
D Y Patil School of Ayurveda and Hospital, D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai |
| 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 PRANALI JADHAV |
DY Patil School of Ayurveda |
1st floor, opd no.1, Department of Kayachikitsa, D Y Patil Vidyanagar, Sector 7, Nerul, Navi Mumbai, 400706.
Thane
MAHARASHTRA |
9665615827
jadhavpranali1412@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, D YPatil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: YOGRATNAKAR, Procedure details: Matra Basti
Dose- 60ml
Duration- 16 days)
(1) Medicine Name: MASHADYA TAILA, Reference: YOGRATNAKAR, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 16 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: YOGRATNAKAR, Procedure details: Nasya
Dose- 6 drops in each nostril
Duration- 14 days)
(1) Medicine Name: MASHADYA TAILA, Reference: YOGRATNAKAR, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed patients fulfilling the subjective criteria of Kara-Pada Tala Kampa,
Sthambha, Chesta Sangha, Vaka Vikruti and gait impairment.
2.Patients of either sex.
3.The patients age more than 50 years.
4.Patients of Kampavata (PD) who were on a fixed dose of levodopa and fit for Basti and
Nasya.
5.Uncomplicated cases with classical symptoms of Parkinsons disease have been selected
irrespective of caste, religion and profession. |
|
| ExclusionCriteria |
| Details |
1. Patients less than 50 years.
2. Patients with severe systemic disorders such as uncontrolled Hypertension, Cardiac problem
like Myocardial Infarction, Ischaemic Heart Disease, Cardiac Arrest, Cardiac Tamponade,
Cardiomyopathy, Unstable Angina, etc., Tuberculosis, Leprosy, Paralysis, Malignant disease etc.
3.Patients unfit for Basti and Nasya |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Clinical symptoms- subjective and objective parameters such as tremors, Bradykinesia, sthambha, gativikriti, avanamna, and vakavikriti after administeration of basti karma or nasya karma |
Basti- 16 days
Nasya- 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate weather Mashadya taila basti is more effective than Mashadya taila nasya in managing symptoms of kampavata (Parkinsons disease) |
Basti- 16 days
Nasya- 14 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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)
|
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
|
Randomized clinical study comparing the efficacy of Mashadya taila basti (Rectal administration) and Mashadya taila nasya (Nasal administration) in managing Kampavata (Parkinson’s disease). The study aims to assess and compare these treatment’s effect on symptoms like tremors, rigidity, gait impairement and cognitive issues. A total 60 patients divided into 2 groups will undergo these therapies. The methodology includes ethical aprroval, informed consent, subjective and objective criteria. (example- Hoehn and Yahr scale). The study highlights the integration of ayurvedic therapies for Parkinson’s and aims to explore their effectiveness compared to conventional treatments.
|