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CTRI Number  CTRI/2025/01/079073 [Registered on: 20/01/2025] Trial Registered Prospectively
Last Modified On: 19/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Suppression of Certain Natural Urges and Dietary Practices on Hemorrhoids (Arshas) in Adults. 
Scientific Title of Study   A CASE CONTROL SURVEY STUDY ON THE ROLE OF VEGADHARANA (SUPPRESSION OF URGES) AND ITS CLINICAL STUDY ON THE EFFECT OF PATHYA APATHYA IN ARSHAS WITH SPECIAL REFERENCE TO VATA MUTRA PURISHA VEGA 
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 Soumyadip Saha 
Designation  JUNIOR RESIDENT 
Affiliation  FACULTY OF AYURVEDA IMS BHU 
Address  DEPARTMENT OF SWASTHAVRITTA and YOGA FACULTY OF AYURVEDA Institute of Medical Sciences Banaras Hindu University VARANASI

Varanasi
UTTAR PRADESH
221005
India 
Phone  9593947340  
Fax    
Email  saha.somu.0077@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mangalagowri V Rao 
Designation  Associate Professor 
Affiliation  FACULTY OF AYURVEDA IMS BHU 
Address  DEPARTMENT OF SWASTHAVRITTA and YOGA FACULTY OF AYURVEDA Institute of Medical Sciences Banaras Hindu University VARANASI

Varanasi
UTTAR PRADESH
221005
India 
Phone  8178704037  
Fax    
Email  mangowri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mangalagowri V Rao 
Designation  Associate Professor 
Affiliation  FACULTY OF AYURVEDA IMS BHU 
Address  DEPARTMENT OF SWASTHAVRITTA and YOGA FACULTY OF AYURVEDA Institute of Medical Sciences Banaras Hindu University VARANASI

Varanasi
UTTAR PRADESH
221005
India 
Phone  8178704037  
Fax    
Email  mangowri@gmail.com  
 
Source of Monetary or Material Support  
Swasthya Rakshan Clinic, OPD No 16D,Indian Medicine Wing, Sir Sunderlal Hospital, Banaras Hindu University, Varanasi, Uttar Pradesha, Pincode 221005, India 
 
Primary Sponsor  
Name  INSTITUTE OF MEDICAL SCIENCES BANARS HINDU UNIVERSITY 
Address  DEPARTMENT OF SWASTHAVRITTA and YOGA FACULTY OF AYURVEDA Institute of Medical Sciences Banaras Hindu University 
Type of Sponsor  Research institution and hospital 
 
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 
SOUMYADIP SAHA  SIR SUNDERLAL HOSPITAL,BANARAS HINDU UNIVERSITY, VARANASI  Department of Swasthavritta and Yoga, Dhanwantari Bhawan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Pincode- 221005.
Varanasi
UTTAR PRADESH 		 9593947340

drsoumyadipsaha07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Surana (Yam) Vataka along with general pathyas for Arshas. , Apathya:General apathyas for Arshas like Viruddhasana (consumption of incompatible foods), Ajeerna-adhyasana (intake of food before digestion of previous meal), etc.
2Comparator ArmDrugClassical(1) Medicine Name: Kankayan Vati, Reference: Bhaisajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: takra(buttermilk)), Additional Information: -
(2) Medicine Name: Haritaki churna, Reference: charak chikitsasthana, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: ushna jala), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients suffering from pittaja & Kaphaja Arshas
Age group between 20 to 60 yrs
Both male & female
Patients willing to participate in the study
Patients having first and second degrees of hemorrhoids 
 
ExclusionCriteria 
Details  Patients aged below 20 and above 60.
Patients not willing to participate in the study.
Thrombosed & strangulated hemorrhoids
Secondary hemorrhoids
Associated with various upadrava like Bhagandara and Parikartika.
HIV, HBsAg, Hepatitis B, C positive, Diabetes Mellitus, Anemia, Hypertension.
Patient having third & fourth-degree hemorrhoids
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
From the survey study- the degree of suppression of natural urges of mutra (urination) pureesha (defecation) and vata (flatus) in apparently healthy individuals and patients suffering from arshas (piles) will be obtained
From clinical study- Pathya Suran Vataka is expected to reduce the occurrence of Arshas in patients 		 For survey study one year & 2 months
For clinical study 3 evaluations will be done at an interval of 15 days for a total period of 30 days 
 
Secondary Outcome  
Outcome  TimePoints 
From the survey study: to present the data about the incidence of any other illness that are mentioned under the context of supression of natural urges in the classics among the subject survey.
From clinical study: Ayurvedic intervention in lifestyle improves quality of life. 		 after 60 days. 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   06/02/2025 
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="2"
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  

The case control survey study will be conducted by enrolling 420 subjects. The subjects will be allocated into two groups, with 210 subjects in each group. The methodology will be based on self-reported information through the validated Vegadharana Assessment scale (developed by Dr. Suman Gihar and Dr. Mangalagowri V Rao). The study population comprises patients attending OPD & IPD of Shalya Tantra, Swasthavritta & Yoga (Group A) and apparently healthy volunteers accompanying the patients, students, or stuffs willing to participate in the study (Group B) in Sri Sunderlal Hospital, IMS, BHU.

For clinical study, about 60 Arshas patients attending OPD & IPD of Shalya Tantra and Swasthavritta and Yoga Sir Sunderlal Hospital, IMS, BHU, will be registered and randomly allocated into Group A and Group B with 30 patients in each group. Randomization will be done by computer-based data sampling method. The informed consent of patients will be obtained; the details of patients will be recorded in the specific case proforma. 3 evaluations will be done by follow-up after 15 days. Patients will be evaluated on the basis of subjective & objective parameters to assess the efficacy of the intervention given to cases and the control group.

 
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