| CTRI Number |
CTRI/2025/02/079886 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Efficacy of add-on Ayurveda and Yoga on pregnancy rates in infertile PCOS women undergoing treatment for infertility |
Scientific Title of Study
Modification(s)
|
Efficacy of add-on Ayurveda and Yoga intervention on reproductive and metabolic outcomes in women with PCOS undergoing ovulation induction cycles: A multicentric randomized controlled trial- AYUR-YOG PCOS. |
| Trial Acronym |
AYUR-YOG PCOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reeta Mahey |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Deptt of Obstetrics & Gynaecology, Mother and Child Block. AIIMS, New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
09818447845 |
| Fax |
|
| Email |
reetamahey52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reeta Mahey |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Deptt of Obstetrics & Gynaecology, Mother and Child Blok. AIIMS, New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
09818447845 |
| Fax |
|
| Email |
reetamahey52@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reeta Mahey |
| Designation |
Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Deptt of Obstetrics & Gynaecology. Mother & Child Block. AIIMS, New Delhi
New Delhi
South
DELHI
110029
India |
| Phone |
09818447845 |
| Fax |
|
| Email |
reetamahey52@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical research |
| Address |
Discovery Research Division
Indian Council of Medical Research
(Ministry of Health & Family Welfare, Govt. of India)
Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi 110029 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Reeta Mahey |
AIIMS, New Delhi |
Deptt of Obstetrics & Gynaecology and Centre of Integrative Medicine (CIMR)
South
DELHI |
9818447845
reetamahey52@gmail.com |
| Anupama Bahadur |
AIIMS, Rishikesh |
Deptt of Obstetrics & Gynaecology and AYUSH Centre
Dehradun
UTTARANCHAL |
09810326959
anupama.bahadur@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
| Institute Ethics Committee |
Approved |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: Aarth, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatpushpa(Anethum Sowa), Reference: API, Kashyap samhita,Kaidev & Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Intervention includes Shatpushpa churna alongwith Yoga and Standard care(OVI). YOGA intervention- Validated customized yoga module will be administered for 6 months. | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard care(OVI) | One tab Letrozole 5mg once a day from day 2 or 3 of menses for 5 days along with addition of Gonadotropin 75 IU onwards in sequential manner ( in subsequent cycles) in case of inadequate follicular response.Participants in the control arm, who do not achieve primary outcome at end of treatment protocol, will be offered a structured 12 week yoga intervention. The yoga module will be identical in structure,content and delivery format to that received by the interventional arm, ensuring consistency. |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Female |
| Details |
Infertile women attending Gynaecology OPD and meeting the Rotterdam criteria for diagnosis of PCOS.
1 Patient with oligo or anovulation with menstrual cycle length more than 35 days
2 Patient with clinical and or biochemical evidence of hyperandrogenism with mFG score greater than or equal to 5
3 serum testosterone greater than or equal to 0.56 ng per ml
4 free androgen index greater than 5
5 Patient with Follicle number per ovary greater than 19 and or ovarian volume greater than equal to 10cc in transvaginal scan done on day 2 to 5
Those having atleast 2 criteria will be labelled as PCOS and those with anovulation criterion with Phenotype A B D will be recruited for the study
Other inclusion criteria will be
A Normal husband semen parameters as per WHO semen analysis 2021 criteria
B Patient with atleast one patent fallopian tube confirmed by hysterosalpingography or saline infusion sonography or laparoscopy
C Patient with controlled thyroid disorders and normal prolactin levels
|
|
| ExclusionCriteria |
| Details |
1. Patient with history of endometriosis
2.Patient is on any contraception or insulin treatment within last 3 months of recruitment
3.Patient with uncontrolled thyroid/prolactin disorder.
4.Those with history of laparoscopic ovarian drilling within last one year
5.Patient with non-classical congenital adrenal hyperplasia
6.Not willing for follow-up
7.Not having smart phone for doing online yoga classes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical pregnancy rate |
7 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Follicular response |
14 days |
| Ongoing pregnancy rate |
12 weeks |
| early abortion rate |
12 weeks |
| Live birth rate |
9 months |
| Quality of life assessment using PCOSQOL-I scale |
0 & 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="402"
Sample Size from India="402"
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)
|
01/04/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Beyond the clinical and hormonal improvements, main outcome for infertile PCOS women is response to ovulation induction (OVI) treatments and pregnancy rates. Long term metabolic health is also one additional concern in these women. We could not find any study published on evaluation of effect of add-on Ayurveda and/or yoga intervention in addition to ovulation induction treatments on pregnancy rate among infertile PCOS women. The present study is being planned to study the effect of add-on ayurveda herb and yoga on clinical pregnancy rate in infertile PCOS women who are undergoing ovulation induction cycles. As no study has evaluated this before, the present study will give us novel results in form of effect of integrated ayurveda and yoga on clinical pregnancy rate in infertile PCOS women undergoing ovulation induction cycles. If proved to improve clinical pregnancy rates and additionally Quality of life assessment using PCOSQOL-I scale, then the add-on ayurveda and yoga may give an insight to integrate these two strategies as routine intervention tools along with starting OVI therapies.
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