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CTRI Number  CTRI/2023/04/051435 [Registered on: 10/04/2023] Trial Registered Prospectively
Last Modified On: 06/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Clinical trial of local application of herbal paste in piles 
Scientific Title of Study   Randomized open controlled clinical study to evaluate the efficacy of Devdalyadi Lepa in the management of Arsha w.s.r. to 3rd and 4th degree Haemorrhoids  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ayushi Atul Joshi 
Designation  PG Scholar 
Affiliation  Yashwant Ayurvedic college  
Address  Yashwant Ayurvedic Medical College PGT and RC Kodoli Dist Kolhapur Shalyatantra Department ground floor OPD no 4

Kolhapur
MAHARASHTRA
416114
India 
Phone  8421280830  
Fax    
Email  ayushi.joshi27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T Srinivas  
Designation  HOD and Professor of Shalyatantra Department  
Affiliation  Yashwant Ayurvedic college  
Address  Yashwant Ayurvedic Medical College PGT and RC Kodoli Dist Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9503147698  
Fax    
Email  drsrinivast@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T Srinivas  
Designation  HOD and Professor of Shalyatantra Department  
Affiliation  Yashwant Ayurvedic college  
Address  Yashwant Ayurvedic Medical College PGT and RC Kodoli Dist Kolhapur

Kolhapur
MAHARASHTRA
416114
India 
Phone  9503147698  
Fax    
Email  drsrinivast@gmail.com  
 
Source of Monetary or Material Support  
Yashwant Ayurvedic Medical college PGT and RC Kodoli Dist Kolhapur Maharashtra  
 
Primary Sponsor  
Name  Dr Ayushi Atul Joshi  
Address  Yashwant Ayurvedic Medical college PGT and RC Kodoli Dist Kolhapur Maharashtra  
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 Ayushi Atul Joshi   Yashwant Ayurved college and hospital   Department of Shalyatantra OPD no 4 Ground floor Yashwant ayurvedic College and hospital Kodoli Kolhapur Kolhapur MAHARASHTRA
Kolhapur
MAHARASHTRA 		 8421280830

ayushi.joshi27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: Third degree haemorrhoids , (2) ICD-10 Condition: K642||Third degree hemorrhoids,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-lepa, लेप (Procedure Reference: Bhaishajya ratnavali chapter 9 shloka 204 205 206, Procedure details: Local application of kasisadi taila in required amount as per size of pile mass once a day for 15 days)
(1) Medicine Name: Kasisadi taila, Reference: Bhaishajya ratnavali chapter 9 shloka 204 205 206, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 15 Days
2Intervention ArmProcedure-lepa, लेप (Procedure Reference: Rasaratna samuchchaya chapter 15 shloka 82, Procedure details: Local application of Devdalyadi lepa in required amount as per size of the pile mass once a day for 15 days)
(1) Medicine Name: Devdalyadi lepa, Reference: Rasaratna samuchchaya chapter 15 shloka 82, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: od, Duration: 15 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group- 18years to 60years
Irrespective of Gender
Diagnosed cases of 3rd and 4th degree haemorrhoids
Diagnosed cases of primary haemorrhoids 
 
ExclusionCriteria 
Details  Patients with 1st degree and 2nd
degree piles
Bleeding piles
Diagnosed cases of secondary haemorrhoids
Piles associated with Perianal abcess fissure fistula
Rectal Prolapse
Known case of Ulcerative Colitis CA Rectum anorectal polyp HIV tuberculosis
Piles with Complications as Infected Thrombosed
Patients with K/C/O associated systemic Disorders
Pregnant and lactating mother 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the decrease in symptoms of haemorrhoids in terms of parameters like Gudavedana Gudastrava Gudakandu Sthanik shoth and mansankura aakar  2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To study the literature of Devdalyadi lepa
To observe the adverse effect if any 		 78 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/05/2023 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Randomized open Controlled Clinical study to evaluate  the efficacy of Devdalyadi lepa in the management of Arsha with special reference to 3rd and 4th degree Haemorrhoids. Study will be carried in OPD of shalyatantra department of Yashwant ayurvedic College and Hospital kodoli . The observation would be drawn on the basis of symptoms after treatment given . 
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