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CTRI Number  CTRI/2024/09/074466 [Registered on: 27/09/2024] Trial Registered Prospectively
Last Modified On: 26/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to compare the efficacy of Haridradi decoction with Kutaj sunthi decoction in the management of piles. 
Scientific Title of Study   Randomised control clinical trial to compare the efficacy of Haridradi Kashay with Kutaj Sunthi Kashay in the management of Raktarsha 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nikita Sarjerao Kharwade 
Designation  MS Scholar Shalyatantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  07972109926  
Fax    
Email  kharwadenikita004@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nitin D Nalawade 
Designation  Associate Professor Shalyatantra Department 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  9822522905  
Fax    
Email  nalawadenitin54@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Nikita Sarjerao Kharwade 
Designation  MS Scholar Shalyatantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune.

Pune
MAHARASHTRA
411011
India 
Phone  07972109926  
Fax    
Email  kharwadenikita004@gmail.com  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011, Maharashtra, India.  
 
Primary Sponsor  
Name  Tilak Ayurveda Mahavidyalaya 
Address  Tilak Ayurveda Mahavidyalaya Department of Shalyatantra 2nd floor 583/2 Rasta Peth Pune 411011 
Type of Sponsor  Private 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 Nikita Sarjerao Kharwade  Seth Tarachand Ramnath Ayurvedic Hospital Pune  OPD NO-7, Surgery ward, Seth Tarachand Ramnath Ayurvedic Hospital Pune
Pune
MAHARASHTRA 		 07972109926

kharwadenikita004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical committe, TAMV pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: RAKTAJA-ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Kutaj-Sunthi Kashay, Reference: Charak Chikitsasthan 14/185, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Goghrut), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Haridradi Kashay, Reference: Gadnigraha (dwitiyakhand) Arshodhikar 4/76, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: madhu), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having Raktarsha (1st degree) will be selected.
Patient with Hb more than 8 gm % 
 
ExclusionCriteria 
Details  Known case of 2nd, 3rd and 4th degree haemorrhoids.
Patients with Hb less than8 gm%.
Pregnancy
Known case of HIV, HBsAg excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decreasing in frequency bleeding per anum  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Decreasing in amount and frequency bleeding per anum  14 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   14/10/2024 
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 - NO
Brief Summary   The study will be intervened by the treatment of Haridradi Kashay and Kutaj-Sunthi Kashay to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. 
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