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CTRI Number  CTRI/2026/01/101678 [Registered on: 20/01/2026] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A research study to check whether Dashamoola suppositories reduce pain after surgery for anal and rectal problems 
Scientific Title of Study   A randomized controlled clinical study to evaluate the effect of dashamoola rectal suppository in post operative pain management in ano rectal diseases 
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 Apeksha Sayannavar 
Designation  Post graduate scholar 
Affiliation  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal 
Address  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal Department of shalya tantra opd no.16
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal Department of shalya tantra opd no.16
Koppal
KARNATAKA
583231
India 
Phone  8867914208  
Fax    
Email  7sayannavar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrGeetanjali hiremath 
Designation  Associate professor and Guide 
Affiliation  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal 
Address  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal Department of shalya tantra opd no.16
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal Department of shalya tantra opd no.16
Koppal
KARNATAKA
583231
India 
Phone  7760346752  
Fax    
Email  sanjalihiremath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geetanjali hiremath 
Designation  Associate professor and Guide 
Affiliation  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal 
Address  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal Department of shalya tantra opd no.16
Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal Department of shalya tantra opd no.16
Koppal
KARNATAKA
583231
India 
Phone  7760346752  
Fax    
Email  sanjalihiremath@gmail.com  
 
Source of Monetary or Material Support  
Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital,koppal 
 
Primary Sponsor  
Name  Dr Apeksha sayannavar 
Address  Shree jagadguru gavisiddheshwara ayurvedic medical college and hospital,koppal,Karnataka,India 583231 
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 Apeksha Sayannavar  Shri Jagadguru Gavisiddeshwar Ayurvedic Medical College Koppal  Department of shalya tantra opd no.16
Koppal
KARNATAKA 
08867914208

7sayannavar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,SJGAMC,KOPPAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K629||Disease of anus and rectum, unspecified. Ayurveda Condition: GUDARTIH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-DiclofenacDiclofenac suppository 100mg BD for 5 days through rectal route
2Intervention ArmDrugClassical(1) Medicine Name: Dashmoola, Reference: charakasamhita sutrasthana , Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of age group between 18-60 years, either of caste, gender, religion,
occupation and complaining of post operative Ano-rectal pain.Patients who arc undergoing Fissurcctomy, Fistulotomy, Fistulcctomy,
Hcmorrhoidcctomy, kshara lcanna and kshara sutra trans ligation for Arshas will be selected
Ano-rectal Surgeries which will be conducted in SJGAMC, Koppal! 
 
ExclusionCriteria 
Details  Patients with kco Chrons disease
Ulcerative colitis
Ischacmic heart disease
Carcinoma of rectum
Pregnant or lactating women
Uncontrolled Diabetes mellitus more than 250mgdl
Uncontrolled hypertension more than150 by 100 mmHg
Tuberculosis
Positive for human immunodeficiency virus HIV, HCV
Hepatitis-B and C 
 
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 
Progressive relief from pain due to surgical intervention at operative site   Assesment on 1st 3rd & 5th post operative day for gradual relief of pain according to VAS scale 
 
Secondary Outcome  
Outcome  TimePoints 
Progressive relief from pain due to surgical intervention at operative site within 5 days
 
Assesment on 1st 3rd & 5th post operative day for gradual relief of pain according to VAS scale 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 3 
Date of First Enrollment (India)   02/02/2026 
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="0"
Months="6"
Days="10" 
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  
The post-operative pain is unavoidable complaint after any surgery. According to International association for the study of pain, it is an unpleasant sensory and emotional experience associated with acute or potential tissue damage Pain relief has significant
physiological benefits, hence, monitoring of pain relief is increasingly becoming an important postoperative quality measure. The prevalence of post-operative pain after day care surgery within 30 mins is 58%, after 24hrs is 55.3percentage , after 48hrs is 34.7percentage 
The goal for postoperative pain management is to reduce or eliminate pain and discomfort with a minimum side effect. ln contemporary science pain management is widely explained, in which Diclofenac suppository is one of the treatment modalities which is used to manage postoperative anorectal pain. These can encompass headache, dizziness, lightheadedness, drowsiness, loss of appetite, local rectal irritation, ringing in the ears and rectal bleeding In Ayurveda, it’s believed that pain arises due to an imbalance in the Vata dosha. Shoola, is the primary symptom commonly observed in patients following shastra karma procedures. ln Ayurveda pain management is done with Ghrila, Ralcshoghna Dhoopana, Mantra, Agnikarma, Jalaukavacharana, Raktamokshana, /epana, Shastrakarma, vataghna
Upakrama, etc  And while explaining Guda vikaras. Varti is mentioned as one of the main treatment protocols. Suppository is modified form of Varti and it enhances tissue contact time of drug and improves the bioavailability of drug in comparison to conventional local application of drugs. in Ayurveda, treatment modality which alleviates post operative pain is the need of our study. As Dashamoola which is trldoshaghna, vatashamaka, Vedana sthapana and shothaghna as mentioned in Charaka Samhita is widely used drug in all forms in pain management. So, an attempt will be made to manage postoperative Ano-rectal pain through Dashamoola suppository and results shall be compared with Diclofenac suppository.
 
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