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CTRI Number  CTRI/2024/05/067079 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   To study the effect of ayurvedic drug applied locally in rectum prepared from medicinal plant nagkesar and amalaki in the treatment of bleeding piles 
Scientific Title of Study   A single arm clinical study to evaluate the efficacy of nagkesar with amalaki varti in the management of raktaja arsha (bleeding haemorrhoids) 
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 Sagar Verma 
Designation  PG Scholar Shalyatantra 
Affiliation  Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 
Address  OPD Number 3 and IPD Shalyatantra Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 Maharashtra 411018 India Pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  8607150006  
Fax    
Email  sagarsoni426@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Babar 
Designation  Professor and H O D of Shalyatantra Department 
Affiliation  Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 
Address  OPD Number 3 and IPD Shalyatantra Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 Maharashtra 411018 India Pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmai.coml  
 
Details of Contact Person
Public Query  
Name  Dr Sanjay Babar 
Designation  Professor and H O D of Shalyatantra Department 
Affiliation  Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 
Address  OPD Number 3 and IPD Shalyatantra Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18 Maharashtra 411018 India Pune MAHARASHTRA 411018 India

Pune
MAHARASHTRA
411018
India 
Phone  9011035602  
Fax    
Email  sanjaybabar14@gmai.coml  
 
Source of Monetary or Material Support  
Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 
 
Primary Sponsor  
Name  Dr Sagar Verma 
Address  Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 
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 Sagar Verma  Dr D Y Patil College Of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18  OPD No 3 and IPD of Shalyatantra Dr D Y Patil College Of Ayurved And Research Centre Pimpri Pune Maharashtra India 411018
Pune
MAHARASHTRA 		 8607150006

sagarsoni426@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr DYPCA AND RC INSTITUTIONAL ETHICS COMMITTEE PIMPRI PUNE 18   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vartiH, वर्तिः (Procedure Reference: Sushrata Samhita Chikista Sthana 1/55, Procedure details: Varti prepared with Nagkesar and Amalaki will be administered Per Rectum twice a day for 7 days .)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patient diagnosed with 1st and 2nd Degree Raktaja Arsha
2) Patient having signs & symptoms of Raktaja Arsha as
mentioned by ‘Acharya Sushruta’
➢ Sarakta malapravrutti (Bleeding while defecation)
➢ Savedana or Avedana mal nishkasan (Defecation with or
without pain) 
 
ExclusionCriteria 
Details  1) Patient not willing for trial.
2) Pregnant women.
3) Known case of – Severe Anemia, Ulcerative Colitis , Crohns
disease, Tuberculosis of Colon & Rectum , Rectal Prolapse ,
Rectal cancer. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the Raktstambhana properties of Nagkesar with Amalaki Varti in Raktaja Arsha  Assessment will be done on 0th,3rd and 6th day.  
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effect of varti prepared from Nagkesar with Amalaki in Raktaja arsha .  On completion of the treatment. 
 
Target Sample Size   Total Sample Size="31"
Sample Size from India="31" 
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/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
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="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   A single arm clinical study to evaluate the efficacy of Nagkesar with Amalaki Varti in the management of Raktaja Arsha (Bleeding Haemorrhoids). To observe the raktstambhana property of Nagkesar and Amalaki Varti in the management of Raktaja Arsha. Total 31 patients diagnosed with Raktaja Arsha Will be administered with Varti prepared from Nagkesar with Amalaki twice a day for 7 days . Assesment will be done on 0 , 3rd and 6th day and conclusion will be drawn on the basis of statistical method.  
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