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CTRI Number  CTRI/2024/10/075682 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of ayurvedic Ointment in piles 
Scientific Title of Study   Randomised Controlled clinical study to evaluate the efficacy of Pippalyadi ointment in Arsha with special reference to 1st and 2nd 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  Dr Rohan Mansing Valvi 
Designation  PG Scholar 
Affiliation  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik 
Address  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik

Nashik
MAHARASHTRA
422003
India 
Phone  7020050977  
Fax    
Email  rohanvalvihtc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Santosh Pathak 
Designation  PG Guide 
Affiliation  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik 
Address  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik
Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  7767939759  
Fax    
Email  drsantoshsp@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh Pathak 
Designation  PG Guide 
Affiliation  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik 
Address  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik
Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Nashik
Nashik
MAHARASHTRA
422003
India 
Phone  7767939759  
Fax    
Email  drsantoshsp@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Dr Rohan Mansing Valvi 
Address  Ayurved Seva sangh Ayurved Mahavidyalaya, Ganeshwadi Panchavati Nashik 422003 
Type of Sponsor  Other [Self] 
 
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 Rohan Mansing Valvi  Arogyshala Rugnalaya  OPD no 6 Shalyatantra OPD Ayurved Seva Sangh Ayurved Mahavidyalaya Ganeshwadi Nashik
Nashik
MAHARASHTRA 		 7020050977

rohanvalvihtc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: X piles ointment , Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Pippalyadi Ointment, Reference: Sushrut Chikitsasthana 12/9, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patient Dignosed with I & II degree of Internal Haemorrhoids of both sexes
Patients having following Clinical features of Arsha Raktshrav Saraktamalpravruti Gudashool Gudakandu Patients willing to participate with informed written consent 
 
ExclusionCriteria 
Details  Diagnosed case of Carcinoma of rectum large intenstine prolpase of
rectum rectalpolyps fissure in ano fistula in ano crohns disease
Pregnant women and lactating mother
Severe anaemic patient
Patients having systemic disorders like portal hypertension liver cirrhosis
Patient having immuno compromised disorders
Bledding disorders like haemophillia and purpura 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain and bleeding from 1st and 2nd degree internal haemorrhoids  15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in discomfort  15 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 
Date of First Enrollment (India)   11/11/2024 
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="0"
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  

Current study is based on studying the effect of ayurvedic medicated ointment in first and second degree internal haemorrhoids. 80 patients will be selected for the study . Patients will be divided in two groups , group a will be treated with pippalyadi ointment for 15 days and group b will be treated with x-piles ointment or 15 days. Discussion will be made based on the assessment done with reduction in pain via vas scale and per rectal bleeding.

 
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