| CTRI Number |
CTRI/2025/04/085064 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An remedy for per rectal bleeding. |
|
Scientific Title of Study
|
Impact of Kutaj Ghanvati on bleeding in Hemorrhoids(Rakta Arsh). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanya Mann |
| Designation |
Student final year |
| Affiliation |
A&U Tibbia College and Hospital |
| Address |
Department of Shalya Tantra,A&U Tibbia College and hospital Karol bagh New delhi 110005.
New Delhi
DELHI
110036
India |
| Phone |
7042902873 |
| Fax |
|
| Email |
tanyamann17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Tanya Mann |
| Designation |
Student final year |
| Affiliation |
A&U Tibbia College and Hospital |
| Address |
Department of Shalya Tantra, A&U Tibbia College and hospital Karol bagh New delhi 110005.
New Delhi
DELHI
110036
India |
| Phone |
7042902873 |
| Fax |
|
| Email |
tanyamann17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tanya Mann |
| Designation |
Student final year |
| Affiliation |
A&U Tibbia College and Hospital |
| Address |
Department of SHALYA TANTRA, A&U Tibbia College and hospital Karol bagh New delhi 110005.
New Delhi
DELHI
110036
India |
| Phone |
7042902873 |
| Fax |
|
| Email |
tanyamann17@gmail.com |
|
|
Source of Monetary or Material Support
|
| A&U Tibbia College and Hospital , Ajmal Khan road, Karol Bagh, New Delhi - 110005, India. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65 opposite D block D block Janakpuri Institutional Area Janakpuri New Delhi Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Prashant Rasale |
Ayurvedic & Unani Tibbia College and Hospital |
OPD block Room no 6 Department of Shalya Tantra
Central
DELHI |
9870335830
prashantrasale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurveda of A&U Tibbia College and Hospital. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kutajghan vati, Reference: Charak samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Weeks, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1- Hemorrhoid degree- Patients diagnosed with 1st degree, 2nd degree, 3rd degree, and 4th degree bleeding hemorrhoids.
2- Hemoglobin Levels- Patients with hemoglobin levels greater than 8 gm/dL. |
|
| ExclusionCriteria |
| Details |
Patients will be excluded from the study if they have any of the following conditions:
1. Thrombosed hemorrhoids.
2. Fissure in ano or prolapse of the rectum.
3. Hemorrhoids are associated with ulcerative colitis, tuberculosis (Koch’s disease), diabetes mellitus, or hepatic disorders.
4. Blood dyscrasias.
5. HIV-positive or HbsAg-positive patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess hemostatic activity of Kutaj Ghanvati in the case of bleeding hemorrhoids. |
Pateint will be followed up on 1st, 3rd, 5th, 7th and 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The results of treatment will be classified based on the degree of relief experienced by the patients:
1. Cured: More than 75% relief in signs and symptoms.
2. Improved: 50-75% relief in signs and symptoms.
3. Relieved: 25-50% relief in signs and symptoms.
4. Not Cured: Less than 25% relief in signs and symptoms.
|
The total duration of the study for each patient will be 2 Weeks.
|
|
|
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)
|
30/04/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
My research project has been selected by CCRAS SPARK-03 (session -2024-2025). For which ethical clearance and literature work is in progress . My research will start most probably from February 2025.It will take 2 months to complete this research work Right now I am arranging drugs for my spark research work. After the study initiation the progress report is to be made and have to sent higher authority. After the completion of study I will make discussion statistical analysis and conclude with outcomes as achieved. |