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CTRI Number  CTRI/2023/11/059684 [Registered on: 08/11/2023] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the effect of pratisaraniya ksharakarma in internal haemorrhoids  
Scientific Title of Study   An Open Label Double Arm Clinical Study to Compare the Effect of Gomutra Siddha Apamarga Pratisaraniya Ksharakarma and Udaka Siddha Apamarga Pratisaraniya Ksharakarma in Abhyantara Arshas. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPatel Vishva Rajeshbhai 
Designation  PG Scholar 
Affiliation  Government Ayurvedic Medical College and Hospital Bengaluru 
Address  Department of shalyatangtra OPD NO 10 Government Ayurveda Medical College Bengaluru Dhanwantari road Bengaluru karnataka

Bangalore
KARNATAKA
560010
India 
Phone  7016573745  
Fax    
Email  vishvapatel6298@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasudha A 
Designation  Professor 
Affiliation  Government Ayurvedic Medical College and Hospital Bengaluru 
Address  Department of Shalyatantra OPD NO 10 Government Ayurveda Medical College Bengaluru Dhanwantari road Bengaluru karnataka

Bangalore
KARNATAKA
560010
India 
Phone  9480365291  
Fax    
Email  drvasudha.a@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Srinivas Masalekar 
Designation  Professor and HOD 
Affiliation  Government Ayurvedic Medical College and Hospital Bengaluru 
Address  Department of Shalyatantra OPD NO 10 Government Ayurveda Medical College Bengaluru Dhanwantari road Bengaluru karnataka

Bangalore
KARNATAKA
560010
India 
Phone  9886632966  
Fax    
Email  masalekar@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda Medical College Bengaluru 
 
Primary Sponsor  
Name  Government Ayurveda Medical College Bengaluru 
Address  Dhanwantari Road Bengaluru 560010 
Type of Sponsor  Government medical college 
 
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 Patel Vishva Rajeshbhai  Shri Jayachamarajendra Government Ayurveda and Unani Hospital Bengalore  Shalya tantra OPD Room No 10
Bangalore
KARNATAKA 		 7016573745

vishvapatel6298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Government Ayurvedic Medical College Bengaluru  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. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म___ Gomutra siddha apamargapratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Sushruta Samhita, Procedure details: under aseptic precaution local anasthesia will be given , maximal anal dilatation will be done.slit proctoscope will be inserted into anal canal . Gomutra siddha apamarga pratisaraniya kshara will be applied on pile mass followed by washing with jambeera swarasa.anal canal will be packed.anal pack will be removed after 6 hours.Patient Will be underobservation for 7 days and follow up will be done on 14th and 21st day. )
2Comparator ArmProcedure-kShArakarma, क्षारकर्म___Udakasiddha apamarga_pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Sushruta Samhita, Procedure details: Procedure details: under aseptic precaution local anasthesia will be given , maximal anal dilatation will be done.slit proctoscope will be inserted into anal canal . Udaka siddha apamarga pratisaraniya kshara will be applied on pile mass followed by washing with jambeera swarasa.anal canal will be packed.anal pack will be removed after 6 hours.Patient Will be underobservation for 7 days and follow up will be done on 14th and 21st day. ))
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  Patient above 18 and below 70 years of age.
Patients with clinical features of 1st and 2nd degree haemorrhoids. 
 
ExclusionCriteria 
Details  Associated with any other anorectal diseases Pregnancy and Lactating women
Fecal incontinence
Known case of HBV, HCV & HIV infection
Uncontrolled Diabetes mellitus 1 and 2 Contraindicated for kshara karma as per Ayurveda 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
shrinkage of haemorroidal mass  21 days 
 
Secondary Outcome  
Outcome  TimePoints 
cessation of bleeding per anum
cessation of mucoid discharge per anum
relief of pruritis ani 		 21 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   25/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="5" 
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 - NO
Brief Summary   This is an open label double arm clinical study to compare the effect of Gomutra Siddha Apamarga Pratisaraniya ksharakarma and Udaka Siddha Apamarga Pratisaraniya Ksharakarma in Arshas.
Group A Comprising of 20 patients of internal haemorrhoids will be subjected to Gomutra Siddha Apamarga Pratisaraniya ksharakarma  
Group B Comprising of 20 patients of internal haemorrhoids will be subjected to Udaka Siddha Apamarga Pratisaraniya Ksharakarma 
Patients of both group will be observed for 21 days of followup period. 
primary outcome will be shrinkage of haemorrhoidal mass and secondary outcomes will be cessation of bleeding per anum , cessation of mucoid discharge per anum , relief of pruritis ani . 
 
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