| CTRI Number |
CTRI/2025/02/080801 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Management for Delayed Menses. |
|
Scientific Title of Study
|
Clinical study of effect of Amla Kanji Bhavit Japadi Vati in comparison with progesterone pills on delayed menses (Artavakshaya). |
| 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 Netra Shankar Bhadale |
| Designation |
PG scholar |
| Affiliation |
Bharati Vidyapeeth. |
| Address |
Bharati Vidyapeeth (deemed to be university) College of Ayurveda and Hospital, Department of Prasuti Tantra and Streerog OPD No.10 Katraj Dhankwadi Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
7040536217 |
| Fax |
|
| Email |
netra.bhadale-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mrudula Kulkarni |
| Designation |
Associate Professor, Dept.Of Prasuti Tantra and Stree rog |
| Affiliation |
Bharati Vidyapeeth |
| Address |
Bharati Vidyapeeth (deemed to be university) College of Ayurveda and Hospital, Department of Prasuti Tantra and Streerog OPD No.10 Katraj Dhankwadi Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
8698157761 |
| Fax |
|
| Email |
mrudula.kulkarni@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrudula Kulkarni |
| Designation |
Associate Professor, Dept.Of Prasuti Tantra and Stree rog |
| Affiliation |
Bharati Vidyapeeth |
| Address |
Bharati Vidyapeeth (deemed to be university) College of Ayurveda and Hospital, Department of Prasuti Tantra and Streerog OPD No.10 Katraj Dhankwadi Pune.
Pune
MAHARASHTRA
411043
India |
| Phone |
8698157761 |
| Fax |
|
| Email |
mrudula.kulkarni@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University)College of Ayurved and Hospital,katraj,Dhankawadi, Pune 411043, India. |
|
|
Primary Sponsor
|
| Name |
Dr Netra Shankar Bhadale |
| Address |
Bharati Vidyapeeth (deemed to be) University, College of Ayurved and hospital (department of prasutitantra evam stree roga), katraj-dhankawadi Pune-411043
|
| 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 Netra Shankar Bhadale |
Bharati Vidyapeeth (deemed to be university), College of Ayurved and hospital |
department of prasutitantra evam stree roga opd no. 10. katraj-dhankawadi Pune-411043
Pune
MAHARASHTRA |
7040536217
netra.bhadale-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Ethics Committee[BV(DU)COA-EC] |
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 | Classical | | (1) Medicine Name: Amla Kanji Bhavit Japadi Vati, Reference: Bhaishajya Ratnavali - Yonivyapad Chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshnajala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Progesteron Pills | 5-10 mg OD |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Period of amenorrhea more than 35 days with negative UPT |
|
| ExclusionCriteria |
| Details |
1.Patient with pregnancy and lactation.
2.Patient with known case of
hypertension,DM,Thyroid diseae
3.Patient with severe anemia
4.Patient with congenital anomaly of female
genital tract.
5. patient with malignancy of genital tract.
6. patient with primary amenorrhea.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| After completion of medicine course (1-7 days) menstruation will be started. |
After completion of medicine course (1-7 days) menstruation will be started. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| regular normal flow menstruation. |
3rd day of menstruation or 7 day after last dose of medication. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| 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="2"
Months="0"
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
|
Reproductive health of the female is best judged by menstrual cycle. According to Ayurveda,
normal menstruation is the prime indicator of healthy and normal reproductive system, in
which inter menstrual period is approximately one month. For the menstruation to occur, the HPO axis must be actively coordinated, endometrium must
be responsive to the ovarian hormones (estrogen and progesterone) and the outflow tract must
be patent. Now a days, due to changing lifestyle and stress, menstrual disorders are of great
concern-delayed menses is one of them. The length of menstrual cycle varies from woman to
woman, but average is 28 days. However, a cycle can range in length from 21 - 35 days and
still be normaL. Delayed menses (oligomenorrhea) literally means absence of menstruation more than 35 days
in previously normal menstruation in non-pregnant woman. Common causes of delayed
menses are Stress, Post pills, Psychotropic and Antihypertensive drugs, Pituitary Adenoma
and Sheehan’s Syndrome, PCOS, Premature ovarian failure, Uterine synechiae, Malnutrition,
hypothyroid state and Diabetes.1The treatment opted in modern system of medicine is
hormonal therapy. So, to prevent repeated use of hormonal therapy, its better to use safe
Ayurvedic non-hormonal drug formulation as quoted in *Bhaishajya Ratnavali
Yonivyapadrogadhikar is proposed. Conduct of procedure: 1. Patient is examined in opd , necessary investigation done, considering inclusion exclusion criteria , subjects will be recruited in trial group or control group. 2. Trial drug is given, patient asked for follow up after 7 days from last dose of medication or 3rd day of menses
whichever is earlier. 3. Effect is observed and noted. |