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CTRI Number  CTRI/2020/06/026226 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 23/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Lepana]  
Study Design  Other 
Public Title of Study   Ayurvedic preparation and medicine use in the management of haemorrhoids 
Scientific Title of Study   A Clinical Study to Evaluate the Efficacy of Arshakalp Vati and Snuk-Ksheeradi Lepa in Guda Arsha w.s.r. to 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 MP Singh 
Designation  Professor and Head 
Affiliation  Patanjali Bhartiya Ayurvigyan Evum Anusandhan sansthan  
Address  P.G Department of shalya tantra, Patanjali bhartiya ayurvigyan evum anusandhan sansthan, Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone    
Fax    
Email  manojpratap05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr MP Singh 
Designation  Professor and Head 
Affiliation  Patanjali Bhartiya Ayurvigyan Evum Anusandhan sansthan  
Address  P.G Department of shalya tantra, Patanjali bhartiya ayurvigyan evum anusandhan sansthan, Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone    
Fax    
Email  manojpratap05@gmail.com  
 
Details of Contact Person
Public Query  
Name  Pooja Sinha 
Designation  M.S Scholar  
Affiliation  Patanjali Bhartiya Ayurvigyan Evum Anusandhan sansthan  
Address  P.G Department of shalya tantra, Patanjali bhartiya ayurvigyan evum anusandhan sansthan, Haridwar
Patanjali girls hostel, post office, Patanjali Yogpeeth Phase 1,
Hardwar
UTTARANCHAL
249405
India 
Phone  8171411461  
Fax    
Email  poojasinha2912@gmail.com  
 
Source of Monetary or Material Support  
Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan 
 
Primary Sponsor  
Name  Pooja Sinha 
Address  Patanjali girls hostel, post office, Patanjali Yogpeeth Phase 1, Haridwar 
Type of Sponsor  Other [] 
 
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 
DrManoj Pratap Singh  PATANJALI BHARTIYA AYURVIGYAN EVUM ANUSANDHAN SANSTHAN  PATANJALI YOGPEETH PHASE-1, MAHARISHI DAYANAND GRAM,DELHI-HARIDWAR HIGHWAY, NEAR BAHADARABAD, HARIDWAR
Hardwar
UTTARANCHAL 		 8171411461

manojpratap05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Arshakalp Vati  A vati is prepared with daruharidra,haritaki,mahanimb,nimb,reetha,karpura, raktaniryasa,makoya, ghritakumari,nagadaun. The dose will be 2 tablets of 500mg each BD Before meal with lukewarm water. Duration of study- 3 months 
Comparator Agent  NOT APPLICABLE  Not APPLICABLE 
Intervention  Snuk-ksheeradi lepa  Lepa prepared by Snuhi ksheer and Haridra, Snuhi ksheer will be mixed with haridra powder and pralepa will be made. The lepa will apply on the affected part of the body Bahya-abhyantara. • Two times a day after hot sitz bath.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients age ranging from 18 to 60 years.
The patients having complaints of I and II-degree hemorrhoids will be taken for the study after
screening.
External pile mass of small in size.
Patients willing to undergo trial and ready to give informed and written consent. 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Patients of either sex 18 to 60 years old having hemorrhoids will be selected  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To study the etipathogenesis of hemorrhoids on the basis of ayurvedic parameters.
To study the effect of ayurvedic formulation and lepana karma in the management of hemorrhoids.
To provide reliable cost effective Ayurvedic treatment for hemorrhoids 		 90 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/07/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Patients of either sex and 18 to 60 years 1st or 2nd degree hemorrhoids will be selected. The criteria of assessment will be done on the basis of subjective and objective parameters. Subjective parameters include symptoms like pain in , constipation, bleeding per rectum, prolapse pile mass per rectum. Objective assessment will be done  site-internal/external/-external, Surface- even/uneven/smooth, position- depend on clockwise.
Investigations done will be CBCBTCTESRHIVHBSAGHCVCHEST X RAYif necessary), ProctoscopyColonoscopy & Sigmoidoscopyif necessary).

will be done on of 15 days. Follow up will be done 30 days after completion of trial. 
 
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