| CTRI Number |
CTRI/2026/02/103352 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Trial Evaluating Gunjasuranadi Suppository for Internal Haemorrhoids (Abhyantara Arshas). |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate The Efficacy Of Gunjasuranadi Suppository Over Corect Suppository In The Management Of Abhyantara Arshas (1st&2nddegree 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 Sreenivas Gorantla |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal |
| Address |
OPD NO 16 ,Dept of Shalya Tanytra,Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal,583231.
Koppal
KARNATAKA
583231
India |
| Phone |
9959868646 |
| Fax |
|
| Email |
sreenivasgsvas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lohit Kalal |
| Designation |
Associate Professor |
| Affiliation |
Shri Jagadguru Gavisiddheshwara Ayurvedic Medical College,Koppal |
| Address |
OPD NO 16 Dept of Shalya Tantra,Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal 583231.
Koppal
KARNATAKA
583231
India |
| Phone |
7090116108 |
| Fax |
|
| Email |
dr.lohitkalal7108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lohit Kalal |
| Designation |
Associate Professor |
| Affiliation |
Shri Jagadguru Gavisiddheshwara Ayurvedic Medical College,Koppal |
| Address |
OPD NO 16 Dept of Shalya Tantra,Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal 583231.
Koppal
KARNATAKA
583231
India |
| Phone |
7090116108 |
| Fax |
|
| Email |
dr.lohitkalal7108@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sreenivas Gorantla |
| Address |
OPD NO 16 Dept of Shalya Tantra Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal,Karnataka,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 Gorantla sreenivas |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital,koppal |
OPD No 16 Dept of Shalya Tantra,Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital,koppal,Karnataka,583231
Koppal
KARNATAKA |
9959868646
sreenivasgsvas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College,koppal,Karnataka ,583231. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gunjasuranadi Suppository, Reference: Bharat Bhaishajya Ratnakar, Route: Rectal, Dosage Form: Varti/ Suppository, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: The individual is instructed to adopt lithotomy position and gently administer a
suppository into the anal canal Twice daily for a duration of seven days | | 2 | Comparator Arm (Non Ayurveda) | | - | Corect Suppository | Made by : Meridian enterprises Pvt Ltd |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects aged 21-65 years, irrespective of gender diagnosed with first or second-degree
internal haemorrhoids, having haemoglobin levels greater than 8 gm/dl and presenting
with maximum three pile masses will be selected. |
|
| ExclusionCriteria |
| Details |
Internal Haemorrhoids with associated Ano rectal diseases like Fistula in Ano, Fissure
in Ano, Perianal Abscess, Gluteal Abscess and CA Rectum.
Pregnant women and Lactating mothers.
Known case of any Tuberculosis.
Patients with HIV, Hepatitis B or C and systemic disorders such as Chron’s disease,
Ulcerative colitis, Hypertension, Coronary artery diseases Portal Hypertension and
Diabetes Mellitus.
Patients diagnosed with any malignancy condition. |
|
|
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 |
| Regression of Pile mass with minimum pain and discomfort and minimal expected bleeding. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
Nil |
|
|
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)
|
18/02/2026 |
| 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="1"
Months="2"
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
|
In today’s era, unhealthy food habits, non-fibrous food, sedentary lifestyle, sitting for long hours and disturbed sleep leads to disturbances in gastrointestinal function leading to constipation which is the prime factor for the development of haemorrhoids. It has the prevalence rate of 4.4% up to 36.4% of general population.In about 10 million people incidence is equal in both the genders were occurred at the age between 30-65 years but uncommon below the age group of 20 years. The word haemorrhoids is derived from Greek word Haima (Bleed)+Rhoos (Flower) means bleeding and Latin word Pila means ball. Haemorrhoids are dilated veins within the anal canal in the sub epithelial region formed by radicals of superior middle and inferior rectal veins. Haemorrhoids are classified as internal and external haemorrhoids. Internal haemorrhoids are those which are present with in the anal canal, above the dentate line covered with mucous membrane.Based on prolapse they are divided into 4 degrees (1-4 degrees). Treatment modalities for 1st& 2nd degree haemorrhoids include preventive and therapeutic aspect, where in preventive aspect includes modification of diet and lifestyle and therapeutic aspect, medically by usage of antibiotic’s, laxatives, anti-inflammatory, local application and sitz bath. Para surgically sclerotherapy, banding, cryo therapy, infrared coagulation are adopted which have 15 % reoccurrence with complications as hypochondria pain, tenesmus, mucosal ulceration, anal stricture. In Ayurveda, haemorrhoids can be corelated as Arshas. Arshas is considered as one among the Ashta Mahagadhas .it is the Vyadhi seen in Gudavalli region, characterized by the formation of Mamsaankura which obstructs the Gudamarga where Mandaagni is explained as root cause which trouble patient like enemy.Arshas has symptoms of Mamsanukra in Guda pradesha, Shoola, Raktarshrav. Acharya Sushrutha has outlined four therapeutic approaches for managing Arshas with Aushadha, Shastra, Kshara and Agnikarma. Gudavarti or medicated rectal suppositories, facilitate prolonged mucosal contact and improve drug absorption when compared to topical application.Suppository preparation provides both local and systemic therapeutic benefits due to its ease of administration. Primary aim of this study is to manage Abhyantara Arshas through suppository application. Gunjasuranadi varti is mentioned in Bharat Bhaishajya Ratnakar and Bruhat Nigantu Ratnakara. Gunjasuranadi varti, a formulation which is combination of Gunja, Surana and Kushmanda beeja is classically prescribed for the management of Arshas. For improved ease of administration, this traditional varti has been adapted into a suppository form by cocoa butter and bee wax as base materials. Here the present study is an attempt to scientifically validate the effect of Gunjasuranadi suppository over Corect suppository in the management Abhyantara Arhas (1&2nddegree internal haemorrhoids) |