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CTRI Number  CTRI/2025/03/082935 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 13/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A CLINICAL STUDY COMPARING THE EFFICACY OF APAMARGA AND KARVIRA(SHWET)PRATISARANEEYA TEEKSHNA KSHAR APPLICATION IN THE MANAGEMENT OF ARDRA ARSHA(INTERNAL HAEMARRHOID) 
Scientific Title of Study   A RANDOMISED COMPARATIVE STUDY OF APAMARGA AND KARVIRA (SHWET)PRATISARNEEYA TEEKSHNA KSHAR IN THE MANAGEMENT OF ARDRA ARSHA(INTERNAL HAEMARRHOID) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Priti Beladar 
Designation  Pg Scholar 
Affiliation  Naitional institute of ayurveda 
Address  Shalya tantra department National Istitute of ayurveda Amer road near Zorawar singh gate Jaipur Rajsthan302002 india

Jaipur
RAJASTHAN
302002
India 
Phone  7523869026  
Fax    
Email  pritibind68@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PHemantha Kumar 
Designation  Profsso and Hod 
Affiliation  National Institute of Ayurveda 
Address  Shalya tantra department National Istitute of ayurveda Amer road near Zoravar singh gate Jaipur Rajsthan

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr PHemantha Kumar 
Designation  Profsso and Hod 
Affiliation  National Institute of Ayurveda 
Address  Shalya tantra department National Istitute of ayurveda Amer road near Zoravar singh gate Jaipur Rajsthan

Jaipur
RAJASTHAN
302002
India 
Phone  9414056362  
Fax    
Email  profphknia@gmail.com  
 
Source of Monetary or Material Support  
Research grant 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Deemed to be University Amer Road Near Jorawar Singh Gate Jaipur PIN 302002 India  
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 
Dr Priti Beladar  National Institute of Ayurveda Deemed to be University Jaipur  Out patient and In Patient Department of Shalya Tantra
Jaipur
RAJASTHAN 		 7523869026

pritibind68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta Samhita Sutra sthana Chapter 11, Procedure details: Patients will be positioned in lithotomy on the operating table, & the perianal area will be cleansed using aseptic solutions. Subsequently, sterile draping will be performed using a sterilized cut sheet. Local anesthesia will be administered, & pile masses will be reassessed for their numbers, positions, & sizes using lubricated Arshoyantra. Each pile mass will be selected, cleaned with warm water-soaked cotton swabs, & treated with karveer kshara using Darvimukha Shalaka under direct visualization. Following kshara application, the Arsho Yantra will be closed with a cotton swab, & a waiting period will ensue. Upon observation of the pile mass assuming a color akin to ripe Jambu Phala, any excess kshara will be rinsed off with freshly prepared Nimbu Swarasa, & anal packing will be conducted using Yashtimadhu Taila Pichu. )
2Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta Samhita Sutrasthana Chapter 11, Procedure details: Patients will be positioned in lithotomy on the operating table, & the perianal area will be cleansed using aseptic solutions. Subsequently, sterile draping will be performed using a sterilized cut sheet. Local anesthesia will be administered, & pile masses will be reassessed for their numbers, positions, & sizes using lubricated Arshoyantra. Each pile mass will be selected, cleaned with warm water-soaked cotton swabs, & treated with Apamarga teekshna pratisaraneeya kshara using Darvimukha Shalaka under direct visualization. Following kshara application, the Arsho Yantra will be closed with a cotton swab, & a waiting period will ensue. Upon observation of the pile mass assuming a color akin to ripe Jambu Phala, any excess kshara will be rinsed off with freshly prepared Nimbu Swarasa, & anal packing will be conducted using Yashtimadhu Taila Pichu. )
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Arsha categorized as Mridu, Prasrita,Avagada and Uchchhrita
Patients with Arsha of Pittaja and Raktaja origin.
Diagnosed cases of hemorrhoids of the second and third degree. 
 
ExclusionCriteria 
Details  Patients with concurrent systemic illnesses such as uncontrolled Diabetes mellitus, Hypertension, Malignancy, Hepatitis B, Tuberculosis, and Retrovirus positivity.
Patients with first and fourth-degree internal piles.
Patients with external hemorrhoids and other associated Ano-rectal diseases.
Patients with infective and neoplastic conditions of the rectum, rectal prolapse, pelvic pathology and pregnancy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Changes in Assessment Criteria viz Ruja (Post-operative pain) by the help of VAS (Visual Analogue Scale )(1,7,15,21,28), Rakta Srava (Bleeding) – Amount and Frequency (Likert Scale)(1,7,15,21,28), Video rectoscopy(pictosal), Anal sphincter tonicity (measured by Hemantha Kumar Modified Sphincterometer)   Changes in Assessment Criteria viz Ruja (Post-operative pain) by the help of VAS (Visual Analogue Scale ) will be donw at 1st,7th,15th,21st and 28th day, Rakta Srava (Bleeding) – Amount and Frequency (Likert Scale)will be assessed at 1st,7th,15th,21st and 28th day, Video rectoscopy(pictosal) will be done at 28th day, Anal sphincter tonicity (measured by Hemantha Kumar Modified Sphincterometer) will be assessed at 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
QOL( Quality of life )- S.F. – 12  Assessment done at the end of 28th day 
 
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 2 
Date of First Enrollment (India)   01/05/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pritibind68@gmail.com].

  6. For how long will this data be available start date provided 01-06-2027 and end date provided 01-06-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Th study compares the efficacy of Apamarga Pratisarneeya Teekshna Kshar and Karvira (Shwet) Pratisarneeya Teekshna Kshar in managing Ardra Arsha (second and third degree internal haemorhoids) through a ramomized comparative trial of 30 patients. It is assessed by sujective parameters like pain, bleeding and quality of life and objective parameters like sphincter tone and post operative scars etc.  This study aims to evaluate the efficacy of shwet Karavira Pratisaraniya Teekshna Kshara, an unexplored preparation known for its ease of application, storage, and transportation, in treating Arsha when compared to the proven management by  Apamarga Pratisarneeya Teekshna Kshar. 
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