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CTRI Number  CTRI/2025/03/082157 [Registered on: 11/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the efficacy of Panchakola Churna with Takra in the management of Arusha. 
Scientific Title of Study   Randomized Controlled Clinical Trial Of Panchakola Churna With Takra In The Management Of Arsha With Special Reference To First And Second dgree 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  DrSomesh Dilipsingh Varma 
Designation  PG Scholar 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya Shayla Department Gadhinglaj Kolhapur Pin 416502 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shayla Department Gadhinglaj Kolhapur Pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9511630279  
Fax    
Email  Someshvarma42@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Drvinod chaugule 
Designation  Reader of shalyatantra department 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya Shayla Department Gadhinglaj Kolhapur Pin 416502 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shayla Department Gadhinglaj Kolhapur Pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9975720283  
Fax    
Email  Vinodchaugale9@gmail.com  
 
Details of Contact Person
Public Query  
Name  Drvinod chaugule 
Designation  Reader of shalyatantra department 
Affiliation  Late Kedari Redekar Ayurvedic Mahavidyalaya Shayla Department Gadhinglaj Kolhapur Pin 416502 
Address  Late Kedari Redekar Ayurvedic Mahavidyalaya Shayla Department Gadhinglaj Kolhapur Pin 416502

Kolhapur
MAHARASHTRA
416502
India 
Phone  9975720283  
Fax    
Email  Vinodchaugale9@gmail.com  
 
Source of Monetary or Material Support  
Daily OPD patients Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur Maharashtra India PIN. 416502 
 
Primary Sponsor  
Name  Dr somesh dilipsingh varma  
Address  Late Kedari Redeakr Ayurvedic Mhavidyalaya Gadhinglaj Kolhapur Maharashtra India PIN 416502 
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 SOMESH DILIPSINGH VARMA  Late Kedari Redekar Ayurvedic Mahavidyalaya .  Department of shalyatantra, Male ward,Female ward and OPD NO.4 Gadhinglaj Kolhapur Maharashtra India PIN. 416502
Kolhapur
MAHARASHTRA 		 9511630279

someshvarma42@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Late Kedari Redeakr Ayurvediac Mahavidyalaya Gadjinglaj, Kolhapur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Samsharkara churna, Reference: Bhaishyajaratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Panchakol churna, Reference: Bhaishyajaratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having age between 20 to 60 years of either sex.
First & Second degree haemorrhoid.
 
 
ExclusionCriteria 
Details  Haemorrhoids associated with fissure or fistula.
Third and fourth degree haemorrhoids, External piles.
Thrombosed and strangulated haemorrhoids.
Haemorrhoids associated with colorectal malignancy.
Haemorrhoids in Antenatal care, postnatal care.
Severe anal stricture with complication.
Patient with known history of Tuberculosis or any other systemic disorders or illness.
Ulcerative colitis.
Patients with Interno or external piles, perianal & perineal abscess.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
relief from symptoms   4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
free from didease  8 weeks 
 
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/ Phase 3 
Date of First Enrollment (India)   10/05/2025 
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 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   This study is Randomized controlled clinical trial to study the efficacy of panchakol churna with takra in the management of arsha w.s.r. to 1st and 2nd degree internal haemorrhoids . study will be carried out in the OPD/IPD of shalyatantra department of Late Kedari Redekar Ayurvedic Mahavidyalaya And Hospital Gadhinglaj. Observation And Conclusion will be Drawn On The Basis Of Symptoms after treatment given . 
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