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CTRI Number  CTRI/2022/02/039948 [Registered on: 02/02/2022] Trial Registered Prospectively
Last Modified On: 25/12/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Clinical Study To Evaluate The Effect of Sarpagandha Ghana Vati and Kusmanda Rasayan After Medical Purgation in Management of Hypertension. 
Scientific Title of Study   Comparative Clinical Study To Evaluate The Efficacy of Sarpagandha Ghana Vati and Kusmanda Rasayan After Virechana in Management of Vyanabala Vaishamya (Essential Hypertension) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gupteswar Mishra 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kayachikitsha All India Institute of Ayurveda Gautampuri, Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone  7978478886  
Fax    
Email  gupteswarmishra4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jonah S 
Designation  Professor Kayachikitsa 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kayachikitsa All India Institute of Ayurveda Gautampuri, Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone    
Fax    
Email  jonahdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gupteswar Mishra 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kayachikitsha All India Institute of Ayurveda Gautampuri, Sarita Vihar New Delhi

South
DELHI
110076
India 
Phone  7978478886  
Fax    
Email  gupteswarmishra4@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Gautam Puri, Sarita Vihar 110076  
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda Gautampuri, Saritavihar New Delhi 110076 
Type of Sponsor  Government 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 
Dr Gupteswar Mishra  All India Institute of Ayurveda  All India Institute of Ayurveda, OPD 1,3,5 and IPD Department of Kayachikitsa Gautampuri, SaritaVihar New Delhi 110076
South
DELHI 		 7978478886

gupteswarmishra4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of All India Institute of Ayurveda, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: SIRORUK ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Sarpagandha Ghana vati, Reference: AFI part II of Vati 10:11, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -Warm Water), Additional Information:
(2) Medicine Name: , Reference: Kusmanda Rasayan, Route: Astanga Hrudaya, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(10), Frequency: g, Bhaishajya Kal: bd, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: -Warm Water
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Systolic blood pressure >140 mm Hg
Diastolic blood pressure >90 mm Hg
Fit for Purgation therapy
Willing to consent  
 
ExclusionCriteria 
Details  Systolic >180 mm Hg, Diastolic >100 mm Hg
Secondary Hypertension (CKD, Endocrine disorder, Type I , Type II diabetic ,pregnancy induced hypertension
Age below 21 and above 70
Unfit for virechana
Hypersensitivity to trail drug
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate and to compare the therapeutic effect of Sarpagandha Ghana Vati and Kushmanda Rasayana in the management of Vyanabala Vaishamya(Essential Hypertension).  106 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in symptoms of Vyanabala Vaishamya (Essential Hypertension)  106 days 
Change in quality of life SF-36 quality of life.   106 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   10/02/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [gupteswarmishra4@gmail.com].

  6. For how long will this data be available start date provided 10-02-2022 and end date provided 10-02-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - no
Brief Summary   Sarpagandha ghana vati is widely practice Ayurveda medicine in treatment of hypertension, as hypertension is raktaja vyadhi according to Ayurveda , Virechana(Medical purgation) followed by Rasayana like Sarpagnadha and other widely use drug Kusmanada Rasayan is taken to trail. 
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