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CTRI Number  CTRI/2021/04/032887 [Registered on: 16/04/2021] Trial Registered Prospectively
Last Modified On: 15/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study The Efficacy Of Krishna Til Choorna And Ghrit In Comparison With Nagkeshara Choorna In The Management Of Raktarsha (Bleeding Piles) 
Scientific Title of Study   A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Krishna Til Choorna And Ghrit In Comparison With Nagkeshara Choorna In The Management Of Raktarsha (Bleeding Piles) 
Trial Acronym  KTGNRABP 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Somnath Govind Wadkar 
Designation  PG First Year 
Affiliation  PDEAS College of Ayurved and Research Centre Nigdi 
Address  Ayurved rugnalaya and sterling multispeciality hospital, Department of shalyatantra OPD no 123 sector no.27,Pradhikaran Nigdi,Pune 411044
PDEAS College of Ayurved and Research Centre,sector No 25,Pradhikaran,Nigdi,Pimpri-Chinchwad,Pune
Pune
MAHARASHTRA
411044
India 
Phone  8149134980  
Fax    
Email  somnathwadkar12@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Madhavi Banarase 
Designation  HOD Shalyatantra Depatment 
Affiliation  PDEAS College of Ayurved and Research Centre Nigdi 
Address  Ayurved rugnalaya and sterling multispeciality hospital, Department of shalyatantra OPD no 123 sector no.27,Pradhikaran Nigdi,Pune 411044
PDEAS College of Ayurved and Research Centre,sector No 25,Pradhikaran,Nigdi,Pimpri-Chinchwad,Pune
Pune
MAHARASHTRA
411044
India 
Phone  9423207569  
Fax    
Email  dr.madhavibanarase209@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Madhavi Banarase 
Designation  HOD Shalyatantra Depatment 
Affiliation  PDEAS College of Ayurved and Research Centre Nigdi 
Address  Ayurved rugnalaya and sterling multispeciality hospital, Department of shalyatantra OPD no 123 sector no.27,Pradhikaran Nigdi,Pune 411044
PDEAS College of Ayurved and Research Centre,sector No 25,Pradhikaran,Nigdi,Pimpri-Chinchwad,Pune
Pune
MAHARASHTRA
411044
India 
Phone  9423207569  
Fax    
Email  dr.madhavibanarase209@gmail.com  
 
Source of Monetary or Material Support  
PDEAS College of Ayurved and research centre sector no 25 Pradhikaran nigadi pune 411044 
 
Primary Sponsor  
Name  PDEAS College of Ayurved and research centre 
Address  sector no 25 Pradhikaran nigadi pune 411044 
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 
Dr Somnath Govind Wadkar  Ayurved rugnalay and sterling multispeciality hospital,nigdi  Department of shalyatantra ,OPD no 123,Ayurved rugnalay and sterling multispeciality hospital,sector no 27 , pradhikaran nigdi ,Pimpri-Chinchwad Pune 411044
Pune
MAHARASHTRA 
8149134980

somnathwadkar12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical commite  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K648||Other hemorrhoids. Ayurveda Condition: RAKTAJA-ARSAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Krishna Tila Choorna and Ghrita  Group A will be treated with Krishna Tila Choorna 2gms to 3gms and Ghrita for 3days Orally 
Comparator Agent  Nagkeshara Choorna  Group B will be treated with nagkeshara choorna 2gms to 3gms for 3days orally 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  patients with 1st , 2nd, 3rd degree haemorrhoids
, bleeding piles 
 
ExclusionCriteria 
Details  Known Case Of:-
Thrombosed Piles
Piles Infected
Fistula in ano
Prolapsed of the rectum
perineal Abscess
Malignancy
Crohns disease
Ulcerative colitis
Rectal polyp
Diverticulitis
Hypertension , Diabeties, Anaemia 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Krishna Tila choorna And Ghrita In comparison with Nagkeshara choorna orally Twice a day for 3 days in the management of Raktarsha.  Difference will be examined on the basis of
1. Gudshil,
2. Gudgata Raktastrav,
3. Gudkandu,
4. Gudstrav

followup will be taken on
Day 1
Day 2
Day 3
Day 7
Day 15
Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
To study the adverse effect If any.   Difference will be examined on the basis of
1. Gudsghil,
2. Gudgata Raktastrav,
3. Gudkandu,
4. Gudstrav

follow up will be taken on
Day 2
Day 3
Day 7
Day 15
Day 30 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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 1/ Phase 2 
Date of First Enrollment (India)   20/04/2021 
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   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   One of the most common ano-rectal conditions is Hemorrhoids. Cause may be in relation to the food or the faulty life style. In common language it is referred as Piles.
The diseases that is troubling the human being since the time immemorial is the Arsha because of its manifestation at the Guda Pradesh which is the “ Moola of Sharira”. Haemorrhoids, also called piles, are vascular structures in the anal canal. They become a disease when swollen or inflamed. The signs and symptoms of haemorrhoids depend on the type present. Internal haemorrhoids are usually present with painless, bright red rectal bleeding when defecating. External haemorrhoids often results in pain and swelling in area of the anus. It is manifested due to disturbed life style or daily routines, improper or irregular diet intake, prolonged standing or sitting, faulty habits of defecation etc. These vitiated doshas get localized in guda vali and pradhan dhamani which further vitiates twak, mans, and meda dhatus due to Annavha stroto dushti lead to development of Arsha.
Krishna Tila choorna with Ghrita , indicated for abhyantar prayog in the management of Raktarshas by Acharya Sharanghar in Sharangdhar samihita
It is clearly mentioned that abhyantar prayog in it cures the Raktarsha. As Krishna Tila Choorna with Ghrita contains Krishna Tila and Ghrita which have Arshoghna property, hence this clinical trial on efficacy of Krishna Tila Choorna with Ghrita in the management of Raktarsha is taken for the study.  
Plenty of Ayurvedic drug available for the treatment of Raktarsha most of them have been proven. Krishna Tila Choorna with Ghrita orally has potential to give relief in symptoms of Raktarsha without any side effects. Krishna Tila Choorna with Ghrita is easily available and cheap as compared to other drugs. Hence, this is an attempt to provide a safe, effective and easily available remedy for Raktarsha.
Life style modification is used as treatment but effective in very few patients. Other drugs are available but they only provide temporary & symptomatic relief. Ayurvedic preparations are being preferred as a treatment, but only few drugs have been proven in the specified disease. Krishna Tila with Ghrita a has been proven in Shool prashanam, Agnimandya,swas, Hikka, gharhi , Stambhak, aampachak, etc. But not proven yet in Raktarsha Krishna Tila has may no side effects and gives may relief Raktarsha.   
There is no previous work done on Krishna Tila and Ghrita on Raktarsha (Bleeding piles) till date, so this drug and disease combination has been selected for the Research topic
 
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