| CTRI Number |
CTRI/2024/03/064427 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of effect of Aparajitamula churna vati on ovulation induction |
|
Scientific Title of Study
|
A Clinical Study of Effect of Aja Dugdha Bhavita Aparajita mula Churnavati on Ovulation Induction |
| 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.Priyanka priyadarshni |
| Designation |
Pg Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Bharati Vidyapeeth(Deemed to be University) Department of Prasuti evam stree roga OPD No 10 College of Ayurved and Hospital Katraj Dhanakwadi
Pune
MAHARASHTRA
411043
India |
| Phone |
8294343418 |
| Fax |
|
| Email |
Priyanka.priyadarshni-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema R Gholap |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Department of Prasuti evam Streeroga Bharati Vidyapeeth Deemed to be University College of Ayurved and hospital OPD no 10 Dhanakwadi campus Satara road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9881076009 |
| Fax |
|
| Email |
seema.gholap@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema R Gholap |
| Designation |
Associate professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| Address |
Department of Prasuti evam Streeroga Bharati Vidyapeeth Deemed to be University College of Ayurved and Hospital OPD no 10 Dhanakwadi campus Satara road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9881076009 |
| Fax |
|
| Email |
seema.gholap@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth deemed to be university |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Priyadarshni |
| Address |
Bharati Vidyapeeth Deemed to be University College of Ayurved |
| 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 Priyanka Priyadarshni |
College of Ayurved and hospital |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and hospital Satara road Pune Department of Prasuti evam stree roga OPD no 10 dhanakawadi campus pune satara road
Pune
MAHARASHTRA |
8294343418
priyanka.priyadarshni-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Deemed to be University pune INDIA college of Ayurved, Pune satara road , Pune 411043 ETHICS COMMITTEE [BV(DU)COA EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, (2) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: ARTAVAVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aprajita Mula choorna Vati, Reference: Bhaishyajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: Aprajita Mula choorna Vati, Reference: Bhaishyajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aprajitamula churna , Reference: Bhaishajya ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: Ajadugdha bhavita Aprajitamula churna vati |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1)Age group 18 – 35 years.
2)Women who have infertility due to anovulation.
3)Irregular menstruation with anovulatory cycle.
4)PCOD with anovulatory cycle.
5)If subject is known anovulatory cycle or multiple small follicles in either of the ovaries three months previous reports will be considered.
|
|
| ExclusionCriteria |
| Details |
1)Ovarian hyperstimulation syndrome.
2)Ovarian dysgenesis
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ovulation induced |
base line 3 days(4th to 6th day of menstruation)for 3 consecutive menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Regular menses
Observation of side effects.
Relief in symptoms of depression, hirsutism etc.
|
base line 3 days(4th to 6th day of menstruation)for 3 consecutive menstrual cycle |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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 |
|
Date of First Enrollment (India)
|
08/04/2024 |
| 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="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
|
Today’s evolving way of life has contributed to a wide range of illness and ailments, among them is Anovulation. There is a cause for concern if ovulation does not occur or occurs seldom in a woman of reproductive age. The mere fact that a woman has periods does not indicate that she is ovulating. Infrequent or lack of ovulation is the most common cause of infrequent menses. Which has a significant influence on women’s psychological, sexual and social well-being. Ovulation process is affected by vitiated vata, pitta, and kapha dosha. Ayurveda aims towards treating the disease in accordance with multiple components like dosha, dushya, srotasa involved, condition of Agni, stages of disease, age of patient etc. Ovulation induction is the procedure by which ovulation is induced by any agent usually by drugs. Hence there is need to check the efficacy of Ayurveda approach on ovulation induction. Aparajita mula is useful in imbalancing of vata, pitta and kapha dosha. As Bhaishyajya ratnavali mentioned Aparajita mula in vandhyatva. Aja dugdha bhavita Aparajita mula has not yet used in ovulation induction. Hence this study has been undertaken. |