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CTRI Number  CTRI/2020/07/026518 [Registered on: 13/07/2020] Trial Registered Prospectively
Last Modified On: 10/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   “To Evaluate The Efficacy Of Pratisaraneeya Muskak Kshara In The Management Of Arsha(INTERNAL HAEMORRHOIDS)”  
Scientific Title of Study   “Clinical Evaluation Of Pratisaraneeya Muskak Kshara In The Mwnagement Of Arsha. (INTERNAL HAEMORRHOIDS)”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  jigisha prajapati 
Designation  second year pg scholar 
Affiliation  GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL 
Address  Department of shalyatantra opd no 24 Government akhandanand ayurved college and hospital bhadra lal darvaja ahmedabad
30/C ROW-HOUSE HARINAGAR VAVOL GANDHINAGAR
Gandhinagar
GUJARAT
380001
India 
Phone  9979742980  
Fax    
Email  jigishasprajapati@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harshit s shah 
Designation  professor and principle 
Affiliation  GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL 
Address  Department of shalyatantra opd no 24 Government akhandanand ayurved college and hospital bhadra lal darvaja ahmedabad
30/C ROW-HOUSE HARINAGAR VAVOL GANDHINAGAR
Gandhinagar
GUJARAT
380001
India 
Phone  9824068760  
Fax    
Email  sejharsh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harshit s shah 
Designation  professor and principle 
Affiliation  GOVERNMENT AKHANDANAND AYURVED COLLEGE AND HOSPITAL 
Address  Department of shalyatantra opd no 24 Government akhandanand ayurved college and hospital bhadra lal darvaja ahmedabad
30/C ROW- HOUSE HARINAGAR VAVOL GANDHINAGAR
Gandhinagar
GUJARAT
380001
India 
Phone  9824068760  
Fax    
Email  sejharsh@gmail.com  
 
Source of Monetary or Material Support  
Government akhandanand ayurved college and hospital LAL DARAVAJA BHADRA AHMEDABAD 
 
Primary Sponsor  
Name  Government akhandanand ayurved college 
Address  Department of shalyatantra opd no 24 Government akhandanand ayurved college and hospital 
Type of Sponsor  Research institution 
 
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 
jigisha prajapati  Government akhandanand ayurved college  Department of shalyatantra opd no 24 Government akhandanand ayurved college and hospital bhadra lal darvaja ahmedabad
Ahmadabad
GUJARAT 		 9979742980

jigishasprajapati@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee Government akhandanand ayurved college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K641||Second degree hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Pratisaraneeya muskak kshara in haemorrhoids  Tikshna Pratisaraneeya muskak kshara(5gm Per Haemorrhoid) will be applied in internal haemorrhoids(Ano Rectal Route) for 1 to 2 minutes and observe the colour of pile mass as pakvajambu phala varnsadris in single sitting after that apply satadhautghrit  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients suffering from first and second degree internal haemorrhoids and they will enrolled irrespective of gender cast religion and having controlled Diabetes mellitus and Hypertention 
 
ExclusionCriteria 
Details  Age having less than 18 years and more than 60 years having third and fourth degree haemorrhoids and other disease like rectal prolepse thrombosed piles malignancy of anorectum HIV positive HBsAG positive kochs disease and other systemic disorders and having uncontrolled Hypertention and Diabetes mellitus cardiac disorders and also pregnant women  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Result will be assessed on the basis of symptoms of bleeding pain and discharge   3 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Comparing protrusion of pile mass per rectum by degree of prolepse  3 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   17/07/2020 
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="2"
Days="15" 
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)?  

Brief Summary   HAEMORRHOIDS ARE ONE OF THE COMMONEST PROBLEM OF ANO RECTAL REGIONAND CAUSE BY SEDENTARY LIFESTYLE IRREGULAR AND INAPPROPRIATE DIET PROLONGED SITTING OR STANDING AND CERTAIN PSYCOLOGICAL DISTURBANCE
ARSHA IS JUST LIKE ENEMY IN THE ANALCANAL WHICH OBSTRUCTS THE PASSAGE OF THE CANAL AND MAKES THE PATIENT SUFFER A LOT 
SO SUSHRUTA MENTIONED FOUR MODALITIES  OF ARSHA AMONG THEM KSHARAKARM HAS BEEN  HAVINGHTHE TOP MOSTMPLACE AMONG ALL SURGICAL AND PARA SURGICAL MEASURES IN AYURVEDA DUE TO ITS EFFICACY LIKE CHHEDYA BHEDYA AND LEKHANA KRANAT SO IT IS USED  AS PRATISARANEEYA KSHARA IN THE MANAGEMENT OF ARSHA 
 
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