| CTRI Number |
CTRI/2024/04/066565 [Registered on: 30/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Tila decoction in Artavkshay with special reference to oligomenorrhea and hypomenorrhea |
|
Scientific Title of Study
|
A Clinical Study to assess the effect of TilaKashay in the management of Artavkshay with special reference to Oligomenorrhoea and Hypomenorrhoea. |
| 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 Chitrangi Dattatray Wagh |
| Designation |
Pg Scholar Prasuti Tantra evum streeroga |
| Affiliation |
Ymt ayurvedic medical college and hospital kharghar navi mumbai |
| Address |
Prasuti tantra evum streeroga department opd no 6 ymt ayurvedic medical college and hospital sector 4 kharghar navi mumbai
3rd floor Prasuti Tantra evum streeroga department Dr GD pol foundation ymt ayurvedic medical college and hospital Pg institute sector 4 kharghar navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8976244248 |
| Fax |
|
| Email |
chitrangiwagh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chitrangi Dattatray Wagh |
| Designation |
Pg Scholar Prasuti Tantra evum streeroga |
| Affiliation |
Ymt ayurvedic medical college and hospital kharghar navi mumbai |
| Address |
Prasuti tantra evum streeroga department opd no 6 ymt ayurvedic medical college and hospital sector 4 kharghar navi mumbai
3rd floor Prasuti Tantra evum streeroga department Dr GD pol foundation ymt ayurvedic medical college and hospital Pg institute sector 4 kharghar navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8976244248 |
| Fax |
|
| Email |
chitrangiwagh@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Laxman Patil |
| Designation |
Associate Professor |
| Affiliation |
Ymt ayurvedic medical college and hospital kharghar navi mumbai |
| Address |
Prasuti tantra evum streeroga department opd no 6 ymt ayurvedic medical college and hospital sector 4 kharghar navi mumbai
3rd floor Prasuti Tantra evum streeroga department Dr GD pol foundation ymt ayurvedic medical college and hospital Pg institute sector 4 kharghar navi mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9320380219 |
| Fax |
|
| Email |
drmangeshpatil21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G D Pol foundation Ymt ayurvedic medical college and hospital Pg institute sector 4 kharghar Navi mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Chitrangi Dattatray Wagh |
| Address |
Prasuti Tantra evum streeroga Opd no 6 Ymt ayurvedic medical college and hospital sector Kharghar Navi Mumbai 410210 Raigarh Maharashtra India |
| 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 Chitrangi Dattatray Wagh |
Ymt ayurvedic medical college and hospital sector 4 kharghar navi mumbai 410210 |
3rd floor Prasuti Tantra evum streeroga department Dr GD pol foundation ymt ayurvedic medical college and hospital Pg institute sector 4 kharghar navi mumbai 410210
Raigarh
MAHARASHTRA |
8976244248
chitrangiwagh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Tilakashay , Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 96(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Hold medicine during menstruation |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients fulfilling cardinal symptoms of Artavkshay, i.e.
a) Interval between 2 menses more than 35 days
b) Duration of menstrual bleeding less than 2 days
c) Menstrual Pain
2. Both married and unmarried women.
|
|
| ExclusionCriteria |
| Details |
1.Patient with Menorrhagia.
2.Pregnant and Lactating Amenorrhoea.
3. Hb Count less than 8gm/dl
4.Congenital Anomalies of uterus or ovaries.
5.Women with any malignancy, uterine fibroid, uterine polyp, endometriosis. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Tilakashay in the management of Artavkshay with special to Oligomenorrhoea and Hypomenorrhoea
1)To evaluate the duration of intermenstrual phase.
2) To evaluate the duration of menstrual phase.
3) To evaluate the amount of menstrual bleeding. |
Treatment will be given for 3 months I.e for 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To study the effect of Tilakashay on Endomentrial thickness |
3 months I.e 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
05/05/2024 |
| 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 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
|
THE PRESENT STUDY IS CLINICAL EXPERIMENTAL STUDY.
TITLE- A CLINICAL STUDY TO ASSESS THE EFFECT OF TILAKASHAY IN THE MANAGEMENT OF ARTAVKSHAY WITH SPECIAL REFERENCE TO OLIGOMENORRHOEA AND HYPOMENORRHOEA
SAMPLE SIZE- 38
STUDY CENTRE- ACADEMIC HOSPITAL
P.G SCHOLAR- DR. CHITRANGI DATTATRAY WAGH
GUIDE- DR. MANGESH LAXMAN PATIL(ASSOCIATE PROFESSOR)
|