| CTRI Number |
CTRI/2024/10/074660 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Shatavari treatment for PCOD |
|
Scientific Title of Study
|
Efficacy and Safety of Shatavari In Women with Polycystic Ovarian Disease Syndrome (PCOD): A
Randomized, Double-Blind, Two-Arm, Placebo-Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SHT-1079-2024-04, Version 1; dt. 27th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashodhara Mhatre |
| Designation |
Director, Sr. Gynaecologist |
| Affiliation |
Director |
| Address |
Zoi Fertility, 2nd Floor, Millennium Tower,
Behind petrol pump, opp. IIT, BSNL Colony,
Powai, Mumbai, Maharashtra 400076
Thane
MAHARASHTRA
400076
India |
| Phone |
9820506222 |
| Fax |
|
| Email |
Yashodhara@zoifertility.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashodhara Mhatre |
| Designation |
Director, Sr. Gynaecologist |
| Affiliation |
Director |
| Address |
Zoi Fertility, 2nd Floor, Millennium Tower,
Behind petrol pump, opp. IIT, BSNL Colony,
Powai, Mumbai, Maharashtra 400076
Thane
MAHARASHTRA
400076
India |
| Phone |
9820506222 |
| Fax |
|
| Email |
Yashodhara@zoifertility.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashodhara Mhatre |
| Designation |
Director, Sr. Gynaecologist |
| Affiliation |
Director |
| Address |
Zoi Fertility, 2nd Floor, Millennium Tower,
Behind petrol pump, opp. IIT, BSNL Colony,
Powai, Mumbai, Maharashtra 400076
Thane
MAHARASHTRA
400076
India |
| Phone |
9820506222 |
| Fax |
|
| Email |
Yashodhara@zoifertility.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited
Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
Plot No-1057-F2, PBN Center,
Road No. 45, Jubilee Hills Hyderabad,
Telangana 500033 India |
| 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 Yashodhara Mhatre |
Zoi Fertility |
Zoi Fertility, 2nd Floor, Millennium Tower,
Behind petrol pump, opp. IIT, BSNL Colony,
Powai, Mumbai, Maharashtra 400076
Thane
MAHARASHTRA |
9820506222
Yashodhara@zoifertility.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee D Y Patil medical college Nerul Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:1||Obstetrics. Ayurveda Condition: GRANTHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Identical Placebo capsule | Capsule containing starch 300mg |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Women between 20-40 years of age.
2.Presence of ovarian volume of more than 10 cm3 in at last one ovary assessed by transvaginal ultrasound (US).
3. The presence of micro polycystic ovaries (more than or equal to 12 follicles per ovary) in at least one ovary assessed by transvaginal ultrasound (US).
4. No hormonal treatment in the 6 months prior the study.
5. LH/follicle-stimulating hormone (FSH) more than 2.5.
6. Absence of any adrenal and/or other endocrine disease.
7. Women willing to undergo transvaginal ultrasound (US) for ovarian assessment.
8. Women able to understand the study requirements and follow other procedures required by the study protocol.
9. Must have the ability and willingness to sign an informed consent and to comply with all study procedures |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in volume of ovaries and follicle count assessed on transvaginal ultrasound scan |
Baseline, Week 8 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in BMI |
Baseline, Week 4, Week 8, Week 12 |
| Mean change in laboratory parameters (HbA1C) |
Baseline, Week 12 |
| Mean change in lipid profile (total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides) |
Baseline, Week 12 |
| Mean change in serum insulin by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) |
Baseline, Week 12 |
| Mean change in serum hormones (Sr. Estradiol- E2, Follicle-Stimulating Hormone, Luteinizing Hormone, Progesterone, Testosterone, Dehydroepiandrosterone Sulfate) |
Baseline, Week 12 |
| Mean change in liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters |
Baseline, Week 12 |
| Mean change in renal (serum creatinine, blood urea nitrogen) parameters |
Baseline, Week 12 |
| Mean change in Thyroid (T3, T4, TSH) parameters |
Baseline, Week 12 |
| Mean change in perceived stress scale score |
Baseline, Week 4, Week 8, Week 12 |
| Proportion of patients experiencing Treatment-Emergent Adverse Events (TEAEs) |
Baseline, Week 4, Week 8, Week 12 |
| Proportion of patients experiencing Treatment-Emergent Serious Adverse Events (TESAEs) |
Baseline, Week 4, Week 8, Week 12 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
13/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="25" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
· All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. · Subjects will be informed about the purpose of the study and signed informed consent will be taken. · Blood sampling will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 4 (Week 12). · All subjects will be followed-up during the study period visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, visit 3 (Week 8) ± 4 days, and visit 4 (Week 12) ± 4 days. · The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study |