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CTRI Number  CTRI/2023/06/054358 [Registered on: 23/06/2023] Trial Registered Prospectively
Last Modified On: 22/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Local application]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Kadali Pratisaraneeya Kshara & Apamarga Pratisaraneeya Kshara in Arsha (Haemorrhoids) 
Scientific Title of Study   Comparative Clinical Study of Kadali Pratisaraneeya Kshara and Apamarga Pratisaraneeya Kshara in Arsha (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 Sunil Kumar Gupta 
Designation  Professor Department of Shalya Tantra 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD no 7 UAU Gurukul Campus Haridwar Uttarakhand
UAU Gurukul campus haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India 
Phone  9997229851  
Fax    
Email  suniljivaidya@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunil Kumar Gupta 
Designation  Professor Department of Shalya Tantra 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD no 7 UAU Gurukul Campus Haridwar Uttarakhand
UAU Gurukul campus haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India 
Phone  9997229851  
Fax    
Email  suniljivaidya@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sunil Kumar Gupta 
Designation  Professor Department of Shalya Tantra 
Affiliation  Gurukul campus UAU Haridwar 
Address  OPD no 7 UAU Gurukul Campus Haridwar Uttarakhand
UAU Gurukul campus haridwar Uttarakhand
Hardwar
UTTARANCHAL
249404
India 
Phone  9997229851  
Fax    
Email  suniljivaidya@yahoo.co.in  
 
Source of Monetary or Material Support  
Gurukul Campus UAU Haridwar Uttarakhand 
 
Primary Sponsor  
Name  UAU Gurukul campus haridwar  
Address  OPD no 7 PG Department of Shalya Tantra Gurukul Campus UAU Haridwar 
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 Amit Kumar Meena  Gurukul campus UAU haridwar  OPD no 7 PG Department of Shalya Tantra UAU Gurukul Campus Haridwar
Hardwar
UTTARANCHAL 		 8920197693

amitsgmeena16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
GURUKUL CAMPUS UAU HARDWAR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, (3) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, (4) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Su. Su.11, 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 then local infiltration anesthesia will be given. With the help of Lignocaine Jelly smeared Arsho yantra (split proctoscope), 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)
2Intervention ArmProcedure-pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः (Procedure Reference: Su.Su. 11, 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 then local infiltration anesthesia will be given. With the help of Lignocaine Jelly smeared Arsho yantra (split proctoscope), 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)
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients of Arsha (Haemorrhoids) between the ages of 16 yrs. to 60 yrs.
2) Patients of Arsha which are Mridu(soft),Prasrita(Extended), Avagada (Deep)
and Uchchhrita (Projected).
3) Diagnosed cases of Internal Haemorrhoids of First degree, second degree and
early case of third degree 
 
ExclusionCriteria 
Details  1)nPatients of Arsha (Haemorrhoids), age less than 16 yrs. and more than 60 yrs.
2) Patients with other systemic illnesses like uncontrolled Diabetes mellitus,
uncontrolled Hypertension, Malignancy, Hepatitis B, Tuberculosis and HIV and
HCV .
3) Chronic case of third degree and Fourth degree internal pile.
4) External Haemorrhoids and other associated Ano-rectal diseases.
5) Infective and Neoplastic conditions of rectum, Rectal prolapse.
6) Pelvic pathology and Pregnancy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in Subjective Parameters-
1) Pain in the anal region (ruja)
2) Bleeding per rectum
3) Itching in anal region (kandu)
4) Constipation (vibandh)
5) Loss of appetite (Mandagni)
6) Anorexia (Aruchi) 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in Objective Parameters-
1) Number of pile mass
2) Size of pile mass
3) Prolapse of pile mass
4) Bleeding per rectum during examination (Rakta srava)
 		 At 1st & 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 1/ Phase 2 
Date of First Enrollment (India)   01/07/2023 
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
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  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 [amitsgmeena16@gmail.com].

  6. For how long will this data be available start date provided 01-07-2023 and end date provided 01-06-0027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   The patients will be selected randomly from OPD/IPD of Gurukul Campus Hospital, U.A.U. Haridwar, (U.K.) India. A written informed consent will be obtained after counseling the patients of Arsha (Haemorrhoids) for participation in the study. A careful Clinical examination and necessary investigations will be carried out as per proforma. After establishing diagnosis, the patients will be registered for Clinical trial. The patients will be asked to stop all the medications or therapy except Kshar karma therapy but drugs like Antihypertensives, medication for hyperglycemia, etc. will continue along with Kshar karma therapy.
30 Patients of Arshas will randomly be selected and randomly divided in two groups (both male & female) for study. 
 GROUPS Group A - 15 Patients of Arsha with Apamarga Pratisarneeya kshara 
 Group B - 15 Patients of Arsha with Kadali Pratisarneeya Kshara
 
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