| CTRI Number |
CTRI/2025/10/095687 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Evaluation of Dugdhikadi Ghrita Per Rectal Instillation in 1st and 2nd Degree Bleeding Piles |
|
Scientific Title of Study
|
Clinical Evaluation of Dugdhikadi Ghrita Per Rectal Instillation in Raktarsha (1st and 2nd Degree Bleeding Piles) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Uppal |
| Designation |
PG scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
OPD No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9103746179 |
| Fax |
|
| Email |
aishwaryauppal21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhoomi Soni |
| Designation |
Associate Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
OPD No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9008637659 |
| Fax |
|
| Email |
bhoomi629@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aishwarya Uppal |
| Designation |
PG Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
| Address |
OPD No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
9103746179 |
| Fax |
|
| Email |
aishwaryauppal21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aishwarya Uppal Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee Haridwar (India) 247667 |
|
|
Primary Sponsor
|
| Name |
Aishwarya Uppal |
| Address |
OPD No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667 |
| 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 Aishwarya Uppal |
Quadra Institute of Ayurveda and Hospital Roorkee Haridwar |
OPD No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital NH58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL |
9103746179
aishwaryauppal21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Quadra Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dugdhikadi Ghrita, Reference: Charaka Chikitsa 14/198, Route: Rectal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with the Signs and symptoms of Raktarsha such as Raktasrava (Bleeding per rectum), Kandu (itching), Vibanda (Constipation), Daha (Burning sensation), Guda Vedana (Pain).
2. Patients between the age group of 18-60 years.
3. The patient having complaints of 1st and 2nd degree bleeding piles.
4. Patients with controlled DM and HTN.
5. Patients willing to undergo trail and ready to give informed and written consent. |
|
| ExclusionCriteria |
| Details |
1. Patient below the age of 18 years and above the age of 60 years.
2. Patient who have HB less than 8 gm%.
3. Third and fourth degree prolapsed intero-external piles.
4. Known case of tuberculosis.
5. Patient suffering from severe systemic disorders such as HIV, Ulcerative colitis, Crohn’s disease, carcinoma of rectum and any hereditary bleeding disorder will be excluded from this study.
6. Patients on Thrombolytic drugs.
7. Patient with uncontrolled DM and HTN.
8. The associated condition like Fistula-in-ano, Fissure-in-ano will be excluded from this study.
9. Patient who are not ready to sign written informed consent. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in Subjective Parameters :
1. Raktsrava (Bleeding per anum)
2. Frequency of bleeding per anum
3. Vibanda (Constipation)
4. Guda Vedana (Pain in anal region)
5. Prolapsed pile mass per rectum
6. Daha (Burning Sensation) |
Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in Objective Criteria:
1. Site
2. Surface
3. Position
4. Size of pile mass
5. Colour of pile mass
|
The follow-up period will be of 1 month after treatment, constituting of 2 follow-ups.
1st visit: 15 days after the completion of treatment
2nd visit: 15 days after 1st follow up.
|
|
|
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 |
|
Date of First Enrollment (India)
|
25/10/2025 |
| 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 is an open randomized prospective study to evaluate the effect of Dugdhikadi Ghrita in Raktarsha for the age group between 18 years to 60 years for duration of 15 days. It will be clinical study of 30 patients suffering from Raktarsha. Patient will randomly selected irrespective of their gender, race, religion, occupation. This clinical study will be conducted with aims and objective to provide better, safe and effective management to the patient of Raktarsha. Total 30 patients will be registered for this study from the OPD/ IPD of surgery department of Uttarakhand Ayurveda University, Quadra Institute of Ayurveda Roorkee and other hospitals. A detailed proforma will be prepared on the basis of Ayurvedic text and allied science. The patient will be registered on this proforma and scoring of different clinical features will be done on the assessment criteria. The diagnosis is done on the basis of Raktarsha Lakshana mentioned in Ayurvedic classical textbooks. The patients were assessed on the basis of subjective and objective parameters before and after treatment. The observation of patients will be done before, during and after completion of trial. Little addition or exclusion may be done as per necessity of the study. |