| CTRI Number |
CTRI/2025/03/083622 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Mango leaves on metabolic health, anthropometric indices and sexual hormone levels in Polycystic Ovarian Syndrome or Disease. |
|
Scientific Title of Study
|
Effect of Mangifera Indica leaves on metabolic health, anthropometric indices and sexual hormone levels in Polycystic Ovarian Syndrome or Disease. |
| 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 Ashwini Patil |
| Designation |
Professor, Head of Department (Physiology) |
| Affiliation |
Symbiosis Medical College for Women |
| Address |
Symbiosis Medical College for Women, Physiology department
Division: NIL
Room no. NIL
QMTI Park Road Khadki
Pune
MAHARASHTRA
412115
India |
| Phone |
9096579060 |
| Fax |
|
| Email |
ashwini.patil@smcw.siu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Kashish Tuteja |
| Designation |
Student, Phase III MBBS |
| Affiliation |
Symbiosis medical college for women |
| Address |
Symbiosis Medical college for women,
department: NIL,
Division: NIL,
Room No. NIL
SUHRC
Pune
MAHARASHTRA
412115
India |
| Phone |
09255408736 |
| Fax |
|
| Email |
kashishtuteja2301@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalyani Mahajan |
| Designation |
Professor, Department of OBGY |
| Affiliation |
Symbiosis Medical College for Women |
| Address |
Symbiosis Medical College for Women, Obstetrics and Gynaecology Department, Division:NIL
Room No. NIL
SUHRC
Pune
MAHARASHTRA
412115
India |
| Phone |
7588786829 |
| Fax |
|
| Email |
kalyanimahajandr@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIU- SRP (Symbiosis International University- Student Research Project) seed funding, Mulshi, Lavale,412115, Pune, India |
|
|
Primary Sponsor
|
| Name |
SIUSRP Symbiosis International University Student Research Project seed funding |
| Address |
Symbiosis International University, Mulshi, Lavale, 412115, Pune, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Ashwini Namdeorao Patil |
Symbiosis Medical College for Women |
Symbiosis University hospital and research center, Physiology Department, Division: NIl, Room no.:NIL
Pune
MAHARASHTRA |
9096579060
ashwini.patil@smcw.siu.edu.in |
| Kashish Tuteja |
Symbiosis Medical College for Women |
Symbiosis University hospital and research center, Student, Department: NIL, Division: NIL, Room no. NIL
Pune
MAHARASHTRA |
9255408736
ashwini.patil@smcw.siu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee of Symbiosis International University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
The inclusion criteria will be as follows:
1. Diagnosis of PCOS [Hrishikesh M, Madhuri P, Laxmi P, Advisors S, Gupte S, Divakar H, et al. FOGSI-ICOG Good Clinical Practice Recommendations GCPR on Update in Managing PCOS in Women. 2024.]
In adult women, the diagnosis of PCOS will be made using the Rotterdam criteria, meeting two of the following three conditions: (Grade A, EL 4)
i) Androgen Excess
[ Biochemical: serum total testosterone
Clinical: persistent acne, Hirsutism, female pattern baldness]
ii) Ovulatory dysfunction( Oligo or anovulatory cycles)
iii) Polycystic Ovarian morphology on Ultrasonography
2. Presentation of acanthosis nigricans with or without obesity is an additional diagnostic criterion for PCOS in adults and adolescents (Grade B, EL 4).
3. Mild prolactinemia and subclinical hypothyroidism are common in PCOS; prolactin, TSH levels will also be taken in consideration (Grade B, EL 4)[22]
4. Age 20 to 25 years old.
5. Willingness to wait till the study duration and then commence any allopathic treatment of PCOS/PCOD.
6. Willingness to provide written Informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Menopause
2. Thyroid disorders
3. Use of hormonal medications for treating
menstrual abnormalities over the previous
three months.
4. Hyperlipidemia [high-density lipoprotein
(HDL) < 50 mg/dL (1.3 mmol/L), low-density
lipoprotein (LDL) > 100 mg/dl, and
triglycerides (TG) > 150 mg/dl, total
cholesterol (TC) > 240 mg/dL(6.21 mmol/L)]
5. Hyperprolactinemia
6. Diabetes
7. Alterations in physical activity levels over the
past 6 months
8. Presently on any medications, including
antihyperglycemic agents, lipid-lowering
medications, contraceptives, corticosteroids,
or any other supplements.
9. Pregnant and lactating women.
10. History of allergic reactions to Mangifera
indica. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study shall provide an insight into the effectiveness of Mangifera indica leaves in the management and treatment of PCOS/PCOD, which shall pave the way for an alternative or adjunctive treatment to standardized management. There is a possibility of an assurance of new, cheaper, and efficient treatment modalities to be redefined in women afflicted with this endocrine and complication-involving disorder. |
8 week intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will provide a framework for future studies on herbal intervention in the management of PCOS/PCOD.
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/04/2025 |
| 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="0"
Months="11"
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 study evaluates their effectiveness in improving metabolic health, anthropometric indices, and sexual hormone levels in women with PCOS. It integrates molecular insights into metabolic dysfunction, reproductive genetics, and cell biology. The research is structured as a funded study, incorporating literature reviews and a scientific approach to validate the therapeutic potential of mango leaves in addressing PCOS-related health concerns.The objectives include investigating their impact on insulin resistance, lipid profiles, blood sugar level, BMI and key reproductive hormones such as LH, FSH, and androgens etc. The methodology involves a clinical study with mango leaf supplementation, where participants will undergo pre- and post-intervention assessments of metabolic and hormonal parameters. Biochemical analyses and statistical evaluations will determine the efficacy of the intervention. Through molecular and clinical insights, this study seeks to validate the therapeutic potential of mango leaves as a nutraceutical intervention for PCOS, offering a natural, evidence-based approach for metabolic and endocrine regulation in affected women.
|