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
|
|
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
|
|
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 Shariraâ€. 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 |