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CTRI Number  CTRI/2015/01/005356 [Registered on: 06/01/2015] Trial Registered Retrospectively
Last Modified On: 17/12/2014
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   CLINICAL STUDY OF MEDICATED ENEMA (PANCHAPRASRUTIKA BASTI) IN SARVANGAGATA KUPITA VATA LAKSHANAS 
Scientific Title of Study   CLINICAL STUDY OF PANCHAPRASRUTIKA BASTI IN SARVANGAGATA KUPITA VATA LAKSHANAS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BVDU/COA/680-2/2012-13 dated 26th feb 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita kukreti 
Designation  MD SCHOLAR 
Affiliation  Bharati Vidyapeeth Deemed University college of Ayurved 
Address  Dept Of Panchakarma Bharati Vidyapeeth Deemed University college of Ayurved Katraj Pune

Pune
MAHARASHTRA
411043
India 
Phone  9764955629  
Fax    
Email  kukreti.ankita@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Surendra M Vedpathak 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed University college of Ayurved 
Address  Dept Of Panchakarma Bharati Vidyapeeth Deemed University college of Ayurved Katraj Pune
Saikrupa Society Dhankawadi Pune Satara Road
Pune
MAHARASHTRA
411043
India 
Phone  7030309088  
Fax    
Email  surendra_vedpathak@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Ankita kukreti 
Designation  MD SCHOLAR 
Affiliation  Bharati Vidyapeeth Deemed University college of Ayurved 
Address  Dept Of Panchakarma Bharati Vidyapeeth Deemed University college of Ayurved Katraj Pune

Pune
MAHARASHTRA
411043
India 
Phone  9764955629  
Fax    
Email  kukreti.ankita@gmail.com  
 
Source of Monetary or Material Support  
Dr Ankita Kukreti 
 
Primary Sponsor  
Name  Dr Ankita Kukreti 
Address  Dept Of Panchakarma Bharati Vidyapeeth Deemed University college of Ayurved Katraj Pune 
Type of Sponsor  Other [self] 
 
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 
Dr Ankita kukreti  Dept Of Panchakarma BVMFS Ayurved Hospital  Bharati Vidyapeeth Medical Campus Katraj Satara Road PUNE
Pune
MAHARASHTRA 		 9764955629

kukreti.ankita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth college of Ayurved Ethical Committee BVDUCOAEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients of both sex between 18 to 70 yrs indicated for basti with Lakshanas of Sarvangagata kupita Vata,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  PANCHAPRASRUTIKA BASTI ( ENEMA)  PANCHAPRASRUTIKA BASTI 480ML (Ingredients - Rock Salt 5gm, Honey 96gm,Seasame oil 96ml, cow ghee 96 ml, Cow milk 192ml) was administered per rectal route daily for 9 consecutive daily. standard operative proceudre of Basti was adopted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with Lakshanas of Sarvangagata kupita Vata like Gatrasphurana, Bhanjana, Sarva Sandhi Sphutita Vedana , Stambhana, Aakshepana, Swapa, Sandhyakunjana, Kampana, Shula, Shotha.
2. Patients will be selected in the age group of 18 to 70 years.
3. Patient indicated for Basti Karma.
4. Patient willing to take Basti.
5. Patient of both sexes will be taken.
 
 
ExclusionCriteria 
Details  1. Patients with intestinal TB, malignancy and other infective disorders.
2. Basti Anarha patients.
3. Patients undergoing other modalities of treatment for Sarvangagata kupita Vata will be excluded.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
improvement in subjective and objective
parameter 		 36 
 
Secondary Outcome  
Outcome  TimePoints 
To find the efficacy
treatment in Sarvangagata Kupita Vata  		 2 years 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   16/09/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not done yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Ayurveda considers  aggravated Vata as the main contributory factor for many disorders. Sarvangagata kupita Vata is one such disorder in which there is Gatrasphurana, Bhanjana, Sarva Sandhigata Sphutita Vedana, Shula, Shotha, Kampan, Stambhan, Swapa. Basti is considered best to treat all Vata Vyadhis.Panchaprasrutika Basti (480 ml) having Madhu (Honey-96 ml),Oil (tail-96ml), cow Ghee- 96ml & Cow milk- 192ml as main ingredients is given 9 days daily in the morning at 9:30- 11 am per rectal route on empty stomach. Majority of Ingredient are having Madhur Rasa, Madhur Vipaka which provides Brumhana of Asthi Majja Dhatus and Snigdha Guna which helps in Vatahara. Panchaprasrutika Basti having Vataghana & Brumhana effect is beneficial in Sarvangagata kupita Vata. Assessment will be done on 1st and 9th day and on follow up  27th and 36th from day of starting treatment. Observations will be recorded and results will be drawn after statistical analysis and final conclusion will be made.


 
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