| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Diclofenac | Diclofenac suppository 100mg BD for 5 days through rectal route | | 2 | Intervention Arm | Drug | Classical | | (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. |