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CTRI Number  CTRI/2023/08/056859 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Mustadiyapana basti with and wihout Konch beej churna in Kampavata(Parkinsons disease) 
Scientific Title of Study   A Comparative Clinical Study Of Mustadiyapana Basti With And Without Konch Beej Churna (Modified Kala Basti Schedule) In Kampavata (Parkinsons Disease) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sneha Joshi 
Designation  Pg Scholar Panchakarma 
Affiliation  Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar 
Address  Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee road Haridwar Uttarakhand

Hardwar
UTTARANCHAL
249405
India 
Phone  8279471872  
Fax    
Email  docsj19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vd Vikram Gupta 
Designation  Professor 
Affiliation  Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar 
Address  Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand

Hardwar
UTTARANCHAL
249405
India 
Phone  8958640973  
Fax    
Email  vdvikram20@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sneha Joshi 
Designation  Pg Scholar Panchakarma 
Affiliation  Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar 
Address  Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand

Hardwar
UTTARANCHAL
249405
India 
Phone  8279471872  
Fax    
Email  docsj19@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar 
 
Primary Sponsor  
Name  Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar 
Address  Patanjali bhartiya ayurvigyan evum anusandhan sansthan patanjali yogpeeth Phase 1 Haridwar roorkee road haridwar uttarakhand 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sneha joshi  patanjali bhartiya ayurvigyan evam anusandhan sansthan   opd no. 4 panchakarma department
Hardwar
UTTARANCHAL 		 8279471872

docsj19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Patanjali Ayurved College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ch.si.1/40, Procedure details: After Abhyang & Swedan done, patient will be asked to comfortably lie down in the left lateral position by keeping his head on his arms in the form of pillow with left leg straight and right leg flexed at the knee joint. Anus and enema nozzle will be anointed by using cotton swab dipped in oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered.)
(1) Medicine Name: Mustadi yapana basti without konch beej churna, Reference: Ch.si.12/15, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 768(ml), Frequency: od, Duration: 9 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ch.si.1/40, Procedure details: After Abhyang & Swedan done, patient will be asked to comfortably lie down in the left lateral position by keeping his head on his arms in the form of pillow with left leg straight and right leg flexed at the knee joint. Anus and enema nozzle will be anointed by using cotton swab dipped in oil. After removing air bubble, appropriate quantity of prepared Niruha Basti will be administered.)
(1) Medicine Name: Mustadi yapana basti with konch beej churna, Reference: Ch.si.12/15, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 768(ml), Frequency: od, Duration: 9 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Patient with age group – 18 -70 yrs.
2.Patient with classical features of Kampavata (Parkinson’s disease).
3.Diagnosed cases of Kampavata (Parkinson’s disease) by MRI (brain), PET scan and symptoms related to the disease will be selected.
4.Patient of any socio-economic status, both sexes and all ethnic origins.
5.Patients fit for Basti Karma.
 
 
ExclusionCriteria 
Details  1.Patient below the age of 18 years and above 70 years.
2.Patients having any other disease-causing Tremors and Bradykinesia excluding Parkinson’s disease on above criteria.
3.Patients suffering from severe Insulin resistance, thyroid abnormalities, or cardiac disease.
4.Patients unfit for Basti Karma.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Kampa(Tremor)
2.Gatisanga (Gait)
3.Vakvikrti (Loss of Speech)
4.Stambha (Rigidity)
 		 9,30 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Picking of pins with hands
2.Buttoning time
3.Marie sign (Blink rate/min)
4.Rapid alternating movements
5.Chest expansion
6.Hand grip power
7.Foot Pressure  		 9,30 days 
 
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)   02/09/2023 
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="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 - NO
Brief Summary  

This study is a Comparative Clinical study of Mustadiyapana Basti with and without Konch beej churna (modified Kala basti) schedule in Kampavata (Parkinson’s disease)

This will be conducted on 40 randomly selected patients from Opd/Ipd of Panchakarma department of Patanjali Bhartiya Ayurvigyan evum Anusandhan Sansthan Haridwar. Patient will be divided into 2 groups- 20 patients will be administered Mustadiyapana basti with Konch beej churna and 20 patients will be administered Mustadiyapana basti without Konch beej churna in modified Kala basti schedule. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. 

 


 
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