| CTRI Number |
CTRI/2025/02/081284 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Triphala Gugglu & Suranadi Lepa in Piles |
|
Scientific Title of Study
|
A clinical study of Triphala Gugglu & Suranadi Lepa in Arsha w.s.r to Hemorrhoid. |
| 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 Deepali Sundari Verma |
| Designation |
Professor & Head |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Shalya Tanta, Government Ayurvedic College
Kadamkuan, Patna Bihar
Patna
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Professor & Head |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Shalya Tanta, Government Ayurvedic College
Kadamkuan, Patna Bihar
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Professor & Head |
| Affiliation |
Government Ayurvedic College |
| Address |
Department of Shalya Tanta, Government Ayurvedic College
Kadamkuan, Patna Bihar
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD-14, Government Ayurvedic College and Hospital, Kadamkuan, Patna, Bihar, India 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital PATNA |
| Address |
Department of Shalya Tantra, Government Ayurvredic College and Hospital, Kadamkuan, Patna, Bihar, India, 800003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjana Kumari |
GACH, PATNA |
OPD-14, 3rd floor Department of Shalya Tantra, Government Ayurvedic College, Kadamkuan
Patna
BIHAR |
9708403577
anjanagupta1503@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMITTEE, PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K640||First degree hemorrhoids. Ayurveda Condition: ARSAH, (2) 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: Triphala Gugglu, Reference: Sharangdhar Samhita, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushna Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Suranadi Lepa, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with age from 20 to 60 years.
2. Patients who are suffering from Arsha 1st & 2nd degree.
3. Irrespective of sex.
4. Patients who will co-operative and ready to give written consent
|
|
| ExclusionCriteria |
| Details |
1. 3rd & 4th degree piles.
2. Thrombosed piles mass
3. Rectal polyp.
4. Carcinoma of rectum
5. Portal hypertension
6. Patients suffering from HIV,HCV,HbSAg etc.
7. Other chronic disease |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical sign and symptom (Bleeding per rectum, Pain in anal region, Constipation, Number of pile mass) |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="0"
Months="1"
Days="15" |
|
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
|
Although there are surgical and para-surgical treatment for Arsha (hemorrhoid) are advocated like Hemorrhoidectomy, Rubber-bandligation,cryo-surgery. kshar -karma, sclerotherapy, Leech therapy etc but all these procedures are not free from complication like pain, discomfort, bleeding etc. In Ayurveda Bhesaja chikitsa is the first line of treatment for “Arsha” that Triphala gugglu with Suranadi lepa is selected for present study.This is noninvasive treatment, easily available and also cost effective to the patients. |