| CTRI Number |
CTRI/2024/05/066871 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
15/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between effect of Nishamalaki and Metformin in women suffering from Polycystic Ovary syndrome (PCOS) |
|
Scientific Title of Study
|
A comparative efficacy study of Nishamalaki and Metformin in women suffering from Polycystic Ovary syndrome (PCOS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BVDU/SDL/NA/ 2024 |
NIL |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poonam Gupte |
| Designation |
Senior Research Assistant |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, Interactive Research School for Health Affairs IRSHA |
| Address |
Dept. of Obesity- Diabetes, Clinical room, Ground floor, Bharati Vidyapeeth Deemed to be University, Interactive Research School for Health Affairs IRSHA Pune Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
02024366920 |
| Fax |
|
| Email |
poonam.gupte@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Gupte |
| Designation |
Senior Research Assistant |
| Affiliation |
Bharati Vidyapeeth Deemed to be University, Interactive Research School for Health Affairs IRSHA |
| Address |
Dept. of Obesity- Diabetes, Clinical room, Ground floor, Bharati Vidyapeeth Deemed to be University, Interactive Research School for Health Affairs IRSHA Pune Satara Road Pune
MAHARASHTRA
411043
India |
| Phone |
02024366920 |
| Fax |
|
| Email |
poonam.gupte@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Girija Wagh |
| Designation |
Co-Investigator, Professor & Head |
| Affiliation |
Bharati Vidyapeeth Medical College Bharati Vidyapeeth (Deemed to be) University |
| Address |
Department of Obstetrics & Gynaecology
Bharati Vidyapeeth Medical College Bharati Vidyapeeth (Deemed to be) University Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
02024373226 |
| Fax |
|
| Email |
girijawagh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Dhootpapeshwar Ltd., 135, Nanubhai Desai Road, Khetwadi, Girgaon, Mumbai,- 400004 |
|
|
Primary Sponsor
|
| Name |
Shree Dhootpapeshwar Ltd. |
| Address |
No 135, Opposite Wilson High School, Nanubhai Desai Road, Khetwadi-Girgaon-400004. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Poonam Gupte |
Bharati Vidyapeeth Deemed University, Interactive Research School for Health Affairs |
Bharati Vidyapeeth (Deemed to be) University, Interactive Research School for Health Affairs (IRSHA),Pune- Satara Road
Pune
MAHARASHTRA |
02024366920
poonam.gupte@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Medical College |
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 | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nishamlaki syrup, Reference: Ashtang Hridaya, Route: Oral, Dosage Form: Dravaka, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin | Tablet Glycomet SR (500)- 1 tablet twice a day post meals with water |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Women in the age group of 18 - 45 years (both inclusive) with no conception
2.Women with the presence of any two of the three Rotterdam criteria: oligomenorrhoea, clinical hyperandrogenism, and polycystic ovarian morphology on ultra-sonography (USG)
3.Individuals willing to abide by the study-related procedures
|
|
| ExclusionCriteria |
| Details |
1.Known history of severe hepatic, renal, or cardiac pathologies viz. portal hypertension, nephropathy, oesophageal varices, myocardial infarction, stroke, arrythmia etc.
2.Known cases of active infections such as tuberculosis, HIV, or hepatitis B etc
3.Known history of congenital anomalies of genital tract, cervical pathologies such as polyp, Ca cervix, uterine pathologies such as fibroid, endometriosis
4.Known history of endocrinopathies such as hypothyroidism, hyperprolactinemia, Cushing’s Syndrome, adrenal tumor, ovarian tumor, and late-onset congenital adrenal hyperplasia
5.Women on anxiolytic, antipsychotic, and antidepressant drugs for the past 6 months
6.Any other conditions which in the opinion of investigator can place the patient at risk or can influence the conduct of study or interpretation of results
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.5% improvement in the insulin and glucose levels in Nishamlaki group comparable to Metformin group
2.Number of participants showing improvement in menstrual cycles comparable in both Nishamlaki and Metformin groups
3.5% improvement in anthropometry and body composition in Nishamlaki group comparable to Metformin group
|
Baseline, day 30, day 60, day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
NA |
|
|
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)
|
15/05/2024 |
| 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="0"
Months="8"
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
|
PCOS is the most common and complex endocrine disease affecting 5–10 % of women of reproductive age. The diagnosis of PCOS is based on the presence of at least two of the following three criteria: chronic anovulation, hyperandrogenism (clinical or biological), and polycystic ovaries, termed Rotterdam criteria. In this study, the herbal formulation Nishamlaki will be evaluated compared to Metformin in PCOS. Women in the age group of 18 - 45 years approaching the outpatient department of Gynecology and Obstetrics will be screened for presence of PCOS, through USG and blood investigations; TSH and HbA1c. Eligible women will be recruited and randomly allocated to either of the two intervention groups; Nishamlaki or Metformin. Further, anthropometry, body composition, Fasting glucose, Insulin, Lipid profile, Leutinizing hormone (LH), Follicle stimulating hormone (FSH), Dehydroepiandrosterone sulphate (DHEAS), Prakruti (body constitution) and quality of life (PCOS-QOL Questionnaire), will be done at baseline. The duration of the study will be 3 months and all above parameters except Prakruti and blood investigations will be done monthly. The blood investigations will be repeated at the end of the study. The study outcomes include; improvement in the insulin and glucose levels in Nishamlaki group comparable to Metformin group, Number of participants showing improvement in menstrual cycles comparable in both Nishamlaki and Metformin groups, improvement in anthropometry and body composition in Nishamlaki group comparable to Metformin group. |