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CTRI Number  CTRI/2024/04/065495 [Registered on: 09/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia
Diagnostic
Screening 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative clinical trial of apamarga and vibhitak kshara in patients of Arsha (third degree internal haemorrhoids) 
Scientific Title of Study   A comparative trial on vibhitaka and apamarga pratisarneeya teekshna kshara in abhyantara arsha (wsr third degree internal 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  Sharad Choudhary 
Designation  MS Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room no. 159, Department of Shalya Tantra, National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  9425370583  
Fax    
Email  dr.sharadchoudhary0029@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof P Hemantha Kumar 
Designation  Professor and HOD, Dept of Shalya Tantra, NIA, Jaipur 
Affiliation  National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA 
Address  Room no. 159, Department of shalya tantra, National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sharad Choudhary 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA 
Address  Room no 159, Department of shalya tantra, National Institute of Ayurveda Jorawar Singh Gate, Amer Road JAIPUR - 302002 (RAJ.) INDIA

Jaipur
RAJASTHAN
302002
India 
Phone  9425370583  
Fax    
Email  dr.sharadchoudhary0029@gmail.com  
 
Source of Monetary or Material Support  
Nageshwar Pharmacy, NIA, JAIPUR 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  NATIONAL INSTITUTE OF AYURVEDA DEEMED TO BE UNIVERSITY JORAWAR SINGH GATE AMER ROAD JAIPUR RAJASTHAN 
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 Sharad Choudhary  NATIONAL INSTITUTE OF AYURVEDA   Room no 159, Department of shalya Tantra, National institute of ayurveda, JORAWAR SINGH GATE,AMER ROAD, JAIPUR (RAJ.) -302002 INDIA
Jaipur
RAJASTHAN 		 9425370583

dr.Sharadchoudhary0029@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta Samhita, Procedure details: The patient will be placed in a lithotomy position on the operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with a sterilized cut sheet. After local anesthesia, lubricated Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vibhitakaksharor ApamargaKshar will be applie)
(1) Medicine Name: Vibhitaki Kshara, Reference: Sushruta Samhita, Route: Rectal, Dosage Form: Kshara, Dose: 2(g), Frequency: od, Duration: 1 Days
2Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta Samhita, Procedure details: The patient will be placed in a lithotomy position on the operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with a sterilized cut sheet. After local anesthesia, lubricated Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vibhitakaksharor ApamargaKshar will be applie)
(1) Medicine Name: Apamarga Kshara, Reference: Sushruta Samhita, Route: Rectal, Dosage Form: Kshara, Dose: 2(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients of Internal Arshabetween the ages of 20 yrs to 60 yrs.
2 Patients of Internal Arshawhich are Mridu, Prasrita, Avagada and Uchchhrita.
3 Patients of Internal Arshahaving Pittajaand Raktajaorigin.
4 Diagnosed case of Internal Haemorrhoidsof third degree.
 
 
ExclusionCriteria 
Details  Patients of Arsha, age less than 20 yrs. and more than 60 yrs.
• Patients with other systemic illnesses like uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis and Retrovirus positive.
1.First, Second, Fourth degree Internal Piles.
2.External Haemorrhoids and other associated Ano-rectal diseases.
3.Infective and Neoplastic conditions of rectum, Rectal prolapse.
• Pelvic pathology and Pregnancy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in the symtoms of post operative pain, bleeding, size of pile mass, colour of pile mass, anal sphincter tonicity  on 7th day, 14th day, 21st day and 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
Improve in quality of life  Weekly for 4 weeks 
 
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 3 
Date of First Enrollment (India)   15/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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 - NO
Brief Summary   The patient will be placed in a lithotomy position on the operation table and the perianal area will be cleaned with aseptic solutions. Then draping will be done with a sterilized cut sheet. After local anesthesia, lubricated Arshoyantra, pile masses will be re-assessed for their numbers, positions and sizes. One pile mass at a time will be selected. The pile mass will be scraped or rubbed and cleaned with cotton swab soaked with warm water. Then the Vibhitakaksharor ApamargaKshar will be applied over the pile mass with the help of DarvimukhaShalakaunder direct vision. As soon as applying the Kshar the opening of the Arsho Yantra will be closed by cotton swab and wait for a period of a hundred Matra Kala. When the colour of pile mass is looked like PakwaJambuPhala, the extra Ksharwill be washed out with freshly prepared NimbuSwarasa. Later the anal packing will be done with YashtimadhuTaila Pichu. All the pile masses will be applied in a single sitting. 
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