| CTRI Number |
CTRI/2023/02/050115 [Registered on: 27/02/2023] Trial Registered Prospectively |
| Last Modified On: |
24/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of yashtimadhu powder in treating menorrhagia |
|
Scientific Title of Study
|
A single arm clinical study to assess the effectiveness of Yashtimadhu Yoga in management
of Raktapradar(Menorrhagia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha Pandharipande |
| Designation |
PG Scholar Prasuti tantra evum Stree roga |
| Affiliation |
YMT Ayurvedic Medical College and Hospital Sector 4, Kharghar, Navi Mumbai |
| Address |
Dr G.D.Pol Foundation
YMT Ayurvedic Medical College and Hospital. P.G.Institute.
Institutional Area, Sector 4, Kharghar, Navi Mumbai, Maharashtra , India 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9131244177 |
| Fax |
|
| Email |
dikshapandharipande@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Mehere |
| Designation |
Hod and Professor of Prasuti tantra evum strirog |
| Affiliation |
YMT Ayurvedic Medical College and Hospital Sector 4, Kharghar, Navi Mumbai |
| Address |
Dr G.D.Pol Foundation
YMT Ayurvedic Medical College and Hospital. P.G.Institute.
Institutional Area, Sector 4, Kharghar, Navi Mumbai, Maharashtra , India 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930940403 |
| Fax |
|
| Email |
seema.mehre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Pandharipande |
| Designation |
PG Scholar Prasuti tantra evum Stree roga |
| Affiliation |
YMT Ayurvedic Medical College and Hospital Sector 4, Kharghar, Navi Mumbai |
| Address |
Dr G.D.Pol Foundation
YMT Ayurvedic Medical College and Hospital. P.G.Institute.
Institutional Area, Sector 4, Kharghar, Navi Mumbai, Maharashtra , India 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9131244177 |
| Fax |
|
| Email |
dikshapandharipande@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurvedic Medical College and Hospital
Sector 4, Kharghar, Navi Mumbai
|
|
|
Primary Sponsor
|
| Name |
DR DIKSHA PANDHARIPANDE |
| Address |
YMT Ayurvedic Medical College and Hospital
Sector 4, Kharghar, Navi Mumbai
|
| Type of Sponsor |
Other [SELF FUNDING] |
|
|
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 DIKSHA PANDHARIPANDE |
YMT Ayurvedic Medical College and Hospital Sector 4, Kharghar, Navi Mumbai |
Dr G.D.Pol Foundation opd no 6 prasuti tantra evum striroga
YMT Ayurvedic Medical College and Hospital. P.G.Institute.
Institutional Area, Sector 4, Kharghar, Navi Mumbai, Maharashtra , India 410210
Raigarh
MAHARASHTRA |
9131244177
dikshapandharipande@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N938||Other specified abnormal uterine and vaginal bleeding. Ayurveda Condition: RAKTAYONIROGAH/ASRUJA/APRAJA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu, Reference: Bhavparakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Tandulodak), Additional Information: -(2) Medicine Name: Sita, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: Tandulodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Female patients of age group between 18 yrs to 45yrs (menopause).
2. Hemoglobin % above 10 gm%.
3. Adenomyosis, Endometriosis.
4. Pelvic Inflammatory Disease |
|
| ExclusionCriteria |
| Details |
1)Bleeding due to all type of Abortion and MTP.
2) Patients with systemic disorders like Thyroid dysfunction, Diabetes mellitus.
3) Patient using IUCD, OC pills.
4)Malignancy.
5)Dysmenorrhoea.
6)Fibroids. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Yashtimadhu choorna in management of Raktapradar(Menorrhagia) |
Yashtimadhu Choorna will be given orally with rice water
Schedule - Twice in a day
Duration - 7 days
Follow up - done on 5,15 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effectiveness of Yashtimadhu choorna in management of
Raktapradar(Menorrhagia) |
Yashtimadhu Churna will be given orally
Schedule - Twice in a Day
Duration - 7 days
Follow up - done on 5,15 days |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE- A single arm clinical study to assess the effectiveness of Yashtimadhu Yoga in management
of Raktapradar(Menorrhagia)
SAMPLE SIZE - 40
MODE OF ADMINISTRATION -
PROCEDURE -
1 DOSE OF DRUG – 12gm twice a day for7 days before food from 20th day to 27th day
of menses for 3 consecutive cycles
2 MODE OF ADMINISTRATION – Orally
3 ANUPAN – Tandulodak (2 pal)
SCHEDULE - TWICE A DAY
DURATION - 7 DAYS
FOLLOW UP - 5 AND 15 DAY OF MENSES FOR 3 CONSECUTIVE CYCLES
STUDY CENTRE - Dr G.D.Pol Foundation
YMT Ayurvedic Medical College and Hospital.
P.G.Institute.
Institutional Area, Sector 4, Kharghar, Navi
Mumbai, Maharashtra , India 410210
PG SCHOLAR - DR. DIKSHA PANDHARIPANDE
GUIDE - DR. SEEMA MEHERE HOD AND PROFESSOR OF PRASUTI TANRA EVUM STRIROGA DEPARTMENT |