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CTRI Number  CTRI/2024/11/076707 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness Of Aralwadi Churna in the treatment Of Arsha. 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Aralwadi Churna In The Management Of Arsha With Special Reference To 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 Ashish Kumar 
Designation  MS SCHOLAR 
Affiliation  Government pg ayurveda college and hospital varanasi 
Address  OPD no.25,shalya tantra departmenrt Rajkeeya ayurveda pg college and hospital chaukaghat, varanasi,221002

Varanasi
UTTAR PRADESH
221002
India 
Phone  7408700248  
Fax    
Email  ashish123kanaujia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suman Yadav 
Designation  Professor and H.O.D department of shalya tantra 
Affiliation  Government pg ayurveda college and hospital varanasi 
Address  OPD no.25,shalya tantra departmenrt Rajkeeya ayurveda pg college and hospital chaukaghat, varanasi,221002

Varanasi
UTTAR PRADESH
221002
India 
Phone  9451965767  
Fax    
Email  yadavsuman2073@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mrigank Shekhar 
Designation  Lecturer 
Affiliation  Government pg ayurveda college and hospital varanasi 
Address  OPD no.25,shalya tantra departmenrt Rajkeeya ayurveda pg college and hospital chaukaghat, varanasi,221002

Varanasi
UTTAR PRADESH
221002
India 
Phone  9453788863  
Fax    
Email  drmrigank.bhu@gmail.com  
 
Source of Monetary or Material Support  
Opd No. 25,Government pg ayurveda college and hospital chaukaghat,varanasi 221002 
 
Primary Sponsor  
Name  Government pg ayurveda college and hospital varanasi 
Address  Rajkeeya ayurveda pg college and hospital chaukaghat, varanasi,221002 
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 Ashish Kumar  Government p.g. ayurvedic medical college and hospital, chaukaghat, varanasi  OPD no.25,shalya tantra departmenrt Rajkeeya ayurveda pg college and hospital chaukaghat, varanasi,221002
Varanasi
UTTAR PRADESH 		 7408700248

ashish123kanaujia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC government pg ayurveda college and hospital varanasi u.p mahayogi guru gorakhnath ayush university gorakhpur u.p.  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: ARSHA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Aralwadi Churna, Reference: यो.र.अर्शो रोगाधिकार श्लोक १६, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Bleeding piles
2. Non bleeding piles
3. Constipation
4. Age between 18-60 years
5. First degree hemorrhoids
6.Second degree hemorrhoids
7.Both sex (male and female)




 
 
ExclusionCriteria 
Details  EXCLUSION CRITERIA :
1.Thrombosed pile mass.
2.Profused bleeding
3.Fissure-in-ano.
4.Fistula-in-ano.
5.Third and fourth degree haemorrhoids.
6.First and second degree haemorrhoids associated with other complications.
7.The pathological conditions such as HIV, HBsAg. etc. will be excluded from the study.
8. Pregnancy.
9.Uncontrolled diabetes.
10.Cancer.
11. Anaemic patients.
12.Any other systemic disease.
13.Age below 18year and above 60 year
14.Addiction-drug, alcohol, tobacco etc.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Pile mass shrinkage
2.Control bleeding
3.Incomplete evacuation of bowel
4.Reduce swelling of anal canal 		 60 DAYS 
 
Secondary Outcome  
Outcome  TimePoints 
TO INCREASE THE QUALITY OF LIFE.  60DAYS 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/12/2024 
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="2"
Months="0"
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   This study is Interventional open Randomized control single arm trial where review of relevant literature from Ayurvedic classics, modern medical science,journals, previous researches and internet in the great depth for conceptualization of etio-pathogenesis of ARSHA w.s.r to HAEMORRHOIDS and probable mode of action of Ayurvedic drugs are taken. Patients will be randomly selected from the OPD/IPD of Department of Shalya Tantra. Government PG Ayurveda College and Hospital, Varanasi. 60 Patients will be studied under 2 groups having 30 patients in each group. 

H1-Aralwadi churna is may be  effective  in the management of Arsha(reductin of pile mass  within7 days).

H2-Aralwadi churna is may be  less effective in the management of Arsha(pile mass is reduced more than 7 days)


 
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