| CTRI Number |
CTRI/2023/06/053487 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
02/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Ashwagandha Ksheerapaka in the management of Primary Infertility with special reference to Anovulation. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess the ovulatory effect of Ashwagandha Ksheerapaka in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation (Beeja Dushti). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jeny Mukesh Bhatt |
| Designation |
PhD Scholar, Assistant Professor |
| Affiliation |
PMTs Ayurveda Mahavidyalaya and Shri Eknath Rugnalaya, Datta nagar, Shevgaon, Ahmadnagar. |
| Address |
PMT Ayurved Medical College, 3rd floor, Stree Rog Prasuti Tantra Department, Datta nagar, Shevgaon, Ahmadnagar.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr J N Daruwale |
| Designation |
Associate Professor |
| Affiliation |
PMTs Ayurveda Mahavidyalaya and Shri Eknath Rugnalaya, Datta nagar, Shevgaon, Ahmadnagar. |
| Address |
PMT Ayurved Medical College, 3rd floor, Stree Rog Prasuti Tantra Department, Datta nagar, Shevgaon, Ahmadnagar.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9765140386 |
| Fax |
|
| Email |
dr.daruwalejafar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeny Mukesh Bhatt |
| Designation |
PhD Scholar, Assistant Professor |
| Affiliation |
PMTs Ayurveda Mahavidyalaya and Shri Eknath Rugnalaya, Datta nagar, Shevgaon, Ahmadnagar. |
| Address |
PMT Ayurved Medical College, 3rd floor, Stree Rog Prasuti Tantra Department, Datta nagar, Shevgaon, Ahmadnagar.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9167541086 |
| Fax |
|
| Email |
dr.jenybhatt@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMT Ayurved Medical College & Hospital,Shevgaon, Ahmadnagar |
| YMT Ayurved Medical College & Hospital,Kharghar, Navi Mumbai. |
|
|
Primary Sponsor
|
| Name |
Dr.Jeny Mukesh Bhatt |
| Address |
103,Sai Leela CHS,Plot no-25,Sector no-21,Kharghar,Navi Mumbai-410210. |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeny Mukesh Bhatt |
YMT Ayurved Medical College & Hospital |
Stree Rog Prasuti Tantra department, OPD no -6, Sector no-4,Kharghar,Navi Mumbai-410210.
Raigarh
MAHARASHTRA |
9167541086
dr.jenybhatt@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| PMT Ayurved Medical College & Hospital |
Approved |
| YMT Ayurved Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Ksheerapaka, Reference: Bhavprakash Yonirogadhikar 70/26, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: -(2) Medicine Name: Clomiphene Citrate, Reference: Infertility Male and Female, Vaclav Insler, Bruno Lunenfeld, 2nd Edition, Pg No-444, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 50(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Known patients with Primary Infertility with Anovulation.
2. Patients with age group between 18-35 years.
3. Patients having regular or irregular menses.
4. Patients with PCOS. |
|
| ExclusionCriteria |
| Details |
1. Congenital anomalies of uterus,ovaries,cervix,vagina(female reproductive organs).
2. Fibroids,Ovarian Tumour,Premature Ovarian Failure,CA Cervix.
3. Known case of Systemic Diseases like DM,Hypothyroidism,Hyperthyroidism. |
|
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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 & compare the ovulatory effect of Ashwagandha Ksheerapaka & Clomiphene Citrate in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation(Beeja Dushti). |
at baseline, 4 weeks, 8 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the complete literature on ovulation as well as Anapatya Vandhya available in texts. |
at baseline, 4 weeks, 8 weeks & 12 weeks. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/06/2023 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The Present Study is a PhD Topic. By PhD Scholar - DR JENY MUKESH BHATT and Guide Name - DR JAFAR DARUWALE. Title - A Randomized Controlled Trial to assess the ovulatory effect of Ashwagandha Ksheerapaka in the management of Haritokt Anapatya Vandhya (Primary Infertility) with special reference to Anovulation (Beeja Dushti). Group A - 50 samples will be given freshly prepared Ashwagandha Ksheerapaka 100 ml once a day early morning (before breakfast) from 5th day to 16th day of menses i.e. for 12 days. Group B - 50 samples will be given Clomiphene Citrate 50 mg once in a day to be given from 5th day of menses for 5 days. Total Duration of Trial is 1 year and 6 months.
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