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CTRI Number  CTRI/2025/02/080951 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 14/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the efficacy of aragvadha pratisarniya kshara in the treatment of gudaarsha (haemorrhoids) 
Scientific Title of Study   A Randomized Control Clinical Trial To Evaluate The Efficacy Of Aragvadha Pratisarniya Kshara In The Management Of Gudaarsha (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 Kapil Vitthal Rathod  
Designation  PG Scholar MS Shalyatantra  
Affiliation  MES Ayurved Mahavidyalaya  
Address  MES Ayurved Mahavidyalaya , 2nd floor shalyatantra department,PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote Khed Ratnagiri

Ratnagiri
MAHARASHTRA
415722
India 
Phone  8208027201  
Fax    
Email  rathod789tushar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Borase 
Designation  HOD and Professor, MS Shalyatantra  
Affiliation  MES Ayurved Mahavidyalaya  
Address  MES Ayurved Mahavidyalaya , 2nd floor shalyatantra department,PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote Khed Ratnagiri

Ratnagiri
MAHARASHTRA
415722
India 
Phone  8329008455  
Fax    
Email  dryogeshborase@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kapil Vitthal Rathod 
Designation  PG Scholar MS Shalyatantra  
Affiliation  MES Ayurved Mahavidyalaya  
Address  MES Ayurved Mahavidyalaya , 2nd floor shalyatantra department,PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote Khed Ratnagiri

Ratnagiri
MAHARASHTRA
415722
India 
Phone  8208027201  
Fax    
Email  rathod789tushar@gmail.com  
 
Source of Monetary or Material Support  
MES Ayurved Mahavidyalaya and attached Parshuram Hospital Ghanekhunt Lote, Khed ,Ratnagiri . 415722 
 
Primary Sponsor  
Name  Dr Kapil Vitthal Rathod  
Address  MES Ayurved Mahavidyalaya Ghanekhunt Lote ,Khed ,Ratnagiri . 415722 
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 Kapil Vitthal Rathod   MES Parshuram Hospital and Research centre   Department of Shalyatantra OPD No 1 Parshuram Hospital and Research centre Ghanekhunt Lote Khed Ratnagiri
Ratnagiri
MAHARASHTRA 		 8208027201

rathod789tushar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MES Ayurved Mahavidyalaya Ethics Committee   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
1Comparator ArmDrugClassical(1) Medicine Name: Kankayan vati, Reference: Sharangdhar samhita madhyam khand, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshnajala ), Additional Information: -
(2) Medicine Name: Abhayarishta, Reference: Bhaishajya Ratnavali adhyaya 9, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -koshnajala ), Additional Information: -
2Intervention ArmProcedure- (Procedure Reference: , Procedure details: )
3Intervention ArmProcedure-Kshar karma (Procedure Reference: Shushrut samhita Sutra sthan ,11 th chapter , Procedure details: Local application of Aragvadha pratisarniya kshara with application of therapy on 0,7th ,15th day with follow up )
(1) Medicine Name: Kankayan vati, Reference: Sharangadhar samhita madhyam khand, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 15 Days
(2) Medicine Name: Abhayarishta, Reference: Bhaishajya ratnavali adhyay 9, Route: Oral, Dosage Form: Arishta, Dose: 15(ml), Frequency: bd, Duration: 15 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients with clinical signs and symptoms of Gudaarsha
2) Patients of 20 – 60 years age groups, irrespective of sex.
3) Patients with piles 2
nd 3
rd and 4th degree piles
 
 
ExclusionCriteria 
Details  1) Patients with 1
st degree piles
2) Patients with other co-morbid condition and other systemic
pathology and other local lesion.
3) Patients with pregnancy and surgical indications
4) More than 60 years and less than 20 years patients.
5) Patients having malignancy, HIV, HBsAG.
6) Patients having severe bleeding piles
 
 
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 
1) effect of Pratisarniya Aragvadha kshar on Gudaarsha
2) changes in the clinical features of patients of Gudaarsha  		 15 days study with application of kshar karma once a week with follow up on 1st 7th 15th day  
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate the methodology of pratisarniya kshar.
2. To evaluate the properties argavadha pratisarniya kshar.
3. Literature review of kshara karma and gudaarsha. 		 15 days study with follow up on 1st 7th 15th day  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   25/02/2025 
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 Yet Recruiting 
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 - 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
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rathod789tushar@gmail.com].

  6. For how long will this data be available start date provided 19-11-2024 and end date provided 01-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Title A Randomized Control Clinical Trial to evaluate the efficacy of aragvadha pratisarniya Kshara in the management of Gudaarsha (haemorrhoids)
Null hypothesis H0 - Aragvadha Pratisarniya Kshara Is Not Effective in the management of Gudaarsha 
Alternate Hypothesis H1 -Aragvadha Pratisarniya Kshara Is Effective in the management of Gudaarsha 
Study Design -Simple Randomized Control Clinical Trial 
Inclusive Criteria -
Patients with clinical signs and symptoms of Gudaarsha,
Patients of Gudaarsha under age group of 20 to 60 years of age irrespective of gender , patients with 2nd 3rd 4th degree piles
Exclusive Criteria -
Patients with 1st degree piles, patients with other comorbid conditions, patients below 20 yrs and above 60yrs, pregnancy and other surgical indications , patients with malignancy HIV HBSAG , patients with bleeding piles
Sample size-60
Group A
Aragvadha Pratisarniya Kshara application on 1st 7th 15th day with follow up on 1st 7th 15th day 
Group B
Kankayan vati 500mg BID with koshna jaala pashchatbhakt
Abhayarishta 15ml BID with koshna jaala pashchatbhakt 
Total Duration of the Study 15 days 
Follow up on 1st 7th 15th day 
Mode of application of therapy - local application 
Assessment criteria 
Objective - number of pile mass , size of pile mass
Subjective - pain in ano , constipation, itching ,per rectal bleeding
Results will be drawn based on assessment criteria and statistical analysis 
 
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