| CTRI Number |
CTRI/2025/05/087491 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study of Eladi Kwath in Raktapradar. |
|
Scientific Title of Study
|
A Single Arm Clinical Study to evaluate the efficacy of Eladi Kwath in Raktapradar w.s.r to Menorrhagia. |
| 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 Sonal Nakate |
| Designation |
PG Scholar |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08454090175 |
| Fax |
|
| Email |
nakates18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishigandha Pol |
| Designation |
PG Guide |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8108150590 |
| Fax |
|
| Email |
nishigandhabhavake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishigandha Pol |
| Designation |
PG Guide |
| Affiliation |
YMT Ayurvedic Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, YMT Ayurved Medical College, Sector - 4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8108150590 |
| Fax |
|
| Email |
nishigandhabhavake@gmail.com |
|
|
Source of Monetary or Material Support
|
| YMT Ayurved Medical College, 3rd floor, Gynaecology Department, Sector - 4, Kharghar, Navi Mumbai - 410210 |
|
|
Primary Sponsor
|
| Name |
YMT Ayurved Medical College and Hospital |
| Address |
3rd floor, Gynaecology Department, Sector - 4, Kharghar, Navi Mumbai - 410210 |
| Type of Sponsor |
Private medical college |
|
|
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 Sonal Nakate |
YMT Ayurvedic Medical College and Hospital |
3rd floor, Gynaecology Department, Sector-4, Kharghar, Navi Mumbai - 410210
Raigarh
MAHARASHTRA |
8454090175
nakates18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee YMT Ayurvedic Medical College Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N71||Inflammatory disease of uterus, except cervix. 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: Eladi Kwath, Reference: Harit Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 25 Days, anupAna/sahapAna: Yes(details: -madhu and sharkara), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients with cyclic excessive per vaginal bleeding for more than 7days or quantity more than 80ml or both with or without clots during menstrual cycle
Hb 10gm or more
Patients with Adenomyosis Fibroid uterus less than 3cms endometriosis and pelvic inflammatory disease |
|
| ExclusionCriteria |
| Details |
Patients with IUCD in utero chronic tubo ovarian mass Tubercular Endometritis Granulosa cell tumor of ovary
Patients with known case of Systemic disorder like hypertension liver cirrhosis
Patients with known case of Hypothyroidism Hyperthyroidism leukemia thrombocytopenia DUB
Suspected cases of Spontaneous threatened or incomplete abortion |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Efficacy of Eladi Kwath in Raktapradar. |
To Evaluate the Efficacy of Eladi Kwath in Raktapradar i.e. at baseline, 4 weeks, 8weeks & 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
15/06/2025 |
| 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
|
It is a Single arm clinical study, 42 patients will be taken, Eladi kwath will be given in 2 pal (96ml ~ 100ml), once a day, before food, starting from 5th day of menses upto the next menses for 3 consecutive menstrual cycles assessment will be done on every 15th day from the 1st baseline visit till 90th day(last visit). After the last visit USG will be done to evaluate the efficacy of drug
Purpose of study - the purpose of this study is to treat Raktapradar (Menorrhagia) in women. |