| CTRI Number |
CTRI/2024/09/074449 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Dhanwantar Ghritam in Guda Arsha |
|
Scientific Title of Study
|
Clinical evaluation of Dhanwantar Ghritam Matra Basti in Guda Arsha Haemorrhoids
|
| Trial Acronym |
ARSH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejas Mishra |
| Designation |
Pg Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| 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 |
9557940036 |
| Fax |
|
| Email |
tejasmishra3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Kumar |
| Designation |
Professor |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| 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 |
9717944844 |
| Fax |
|
| Email |
deardrsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tejas Mishra |
| Designation |
Pg Scholar |
| Affiliation |
Quadra Institute of Ayurveda and Hospital |
| 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 |
9557940036 |
| Fax |
|
| Email |
tejasmishra3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Quadra Institute of Ayurveda
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee, Hardwar, Uttaranchal, India 247667 |
|
|
Primary Sponsor
|
| Name |
Tejas Mishra |
| 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 Saurabh Kumar |
Quadra Institute of Ayurveda And Hospital Roorkee |
Opd No 1 Department of Shalya Tantra Quadra Institute of Ayurveda and Hospital Nh58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar Uttaranchal
Hardwar
UTTARANCHAL |
9717944844
deardrsaurabh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| QIA-IEC |
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 | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta Samhita Chikitsathan 12, Procedure details: 1.The patient will be placed in Left lateral position.
2. Then 50 ml of lukewarm Dhanwantar Ghritam will be loaded in an enema syringe. A
rubber catheter oleated with Ghritam will be attached to the enema syringe.
3. Catheter will be introduced through the anal orifice into the rectum in the direction
parallel to the vertebral column. Dhanwantar Ghritam will be given via enema
syringe.
4. The patient will be asked to take a deep breath and not to shake his body while
introducing the drug.
5. The entry of Vayu inside the Guda will be avoided by leaving a little amount of
Dhanwantar Ghritam.)
(1) Medicine Name: Dhanwantar Ghrita, Reference: Sushruta Samhita Chikitsathan 12, Route: Rectal, Dosage Form: Ghrita, Dose: 50(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient’s age ranging from 18 to 60 years.
2.The patients having complaints of I and II degree internal Hemorrhoids will be taken for the study after screening.
3.Patients willing to undergo trial and ready to give informed and written consent. |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 18 years and above the age of 60 years.
2.Third degree prolapsed internal and external Haemorrhoids.
3.Pregnancy.
4.Congenital deformity.
5.Known case of Carcinoma and Tuberculosis.
6.Rectal prolapsed.
7.Patients suffering from other systemic diseases such as HIV, known case of Hepatitis B, Ulcerative colitis, Crohn’s disease, Cirrhosis of liver and Carcinoma of rectum will be excluded from this study.
8.Patient with uncontrolled DM and HTN.
9.External thrombosed Haemorrhoids.
10.The associated condition like Fistula-in-ano, Fissure-in-ano will be excluded from this study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To help regress the growth of hemorrhoids further into 3rd and 4th degree. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Provide a alternative and safe treatment for hemorrhoids. |
18 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2024 |
| 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 labelled clinical study to evaluate the effect of Dhanwantar Ghritam in
Guda Arsha for the age group of 18 yeaars to 60 years for the duration of 28
days. 30 patients will be selected randomly irrespective of gender, race,
religion, occupation.
The clinical
study aims to provide better safe and effective management to the patient of
Guda Arsha.
Total 30 patients
will be registered for this study from the OPD/IPD of surgery department of
quadra institute of ayurveda, roorkee.
Patients will be
assessed on the basis of subjective and objective parameters before and after
treatment. Detailed proforma will be prepared on the basis of Ayurvedic and
allied sciences.
Observation of
patients will be done before, during and after completion of trial.
|