| CTRI Number |
CTRI/2025/08/092842 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to Evaluate the Efficacy and Safety of She Care Juice in Women with Polycystic Ovarian Disease (PCOD) |
|
Scientific Title of Study
|
A Prospective Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of She Care Juice, in women diagnosed with Polycystic Ovarian Disease (PCOD) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CT/011/25, Version 1.0 dated 10- Jun-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Mishra |
| Designation |
Principal Investigator |
| Affiliation |
Rumedic Hospital |
| Address |
Rumedic Hospital
Rz 524 3 Raj Nagar Part I, Street number 9,
Old Mehrauli Road, Near Shiv Sakti Mandir, Palan, New Delhi 10045
New Delhi
DELHI
110075
India |
| Phone |
08527569065 |
| Fax |
|
| Email |
sanmishra75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Shrawan Daga |
| Designation |
Managing Director |
| Affiliation |
Sandipani Healthcare Pvt Ltd. |
| Address |
Plot No.1 Heavy Industrial Area, Near New Power House Road, Jodhpur, Rajasthan 342003
Jaipur
RAJASTHAN
342003
India |
| Phone |
9929597904 |
| Fax |
|
| Email |
shrawan@krishnaayurved.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manoj Karwa |
| Designation |
Head Clinical Trial & Pharmacovigilance |
| Affiliation |
Auriga Research Private Limited |
| Address |
Auriga Research Private Limited, Plot No. 136, sector 05.IMT Manesar, Gurugram, Haryana 122050, India
Gurgaon
HARYANA
122050
India |
| Phone |
09313367656 |
| Fax |
|
| Email |
manojkarwa@aurigaresearch.com |
|
|
Source of Monetary or Material Support
|
| Sandipani Healthcare Pvt Ltd,Plot No.1 Heavy Industrial Area, Near New Power House Road, Jodhpur, Rajasthan 342003 |
|
|
Primary Sponsor
|
| Name |
Sandipani Healthcare Pvt Ltd. |
| Address |
Plot No.1 Heavy Industrial Area, Near New Power House Road, Jodhpur, Rajasthan 342003 |
| Type of Sponsor |
Other [Ayurvedic Industry] |
|
|
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 Sanjay Mishra |
Rumedic Hospital |
Rz 524 3 Raj Nagar Part I, Street number 9,
Old Mehrauli Road, Near Shiv Sakti Mandir, Palan, New Delhi-10045
New Delhi
DELHI |
8527569065
sanmishra75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSER Independent 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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: She care juice, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Participants will consume 30 ml of She Care Juice twice daily, once in the morning on an empty stomach and once one hour after dinner, throughout the study duration. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Females aged 18 to 45 years, fulfilling at least 2 of following 3 criteria diagnosis of PCOS.
2.History of irregular menstrual cycles e.g., cycle length varying by more than 7 days, or cycles less than 21 days or more than 35 days for at least the past 3 to 6 months, potentially attributed to hormonal imbalance.
3.BMI between 18.5 and 38 kg per m2 inclusive
4.LH and FSH ratio more than 1 will be enrolled in the study.
5.Willing and able to provide written informed consent and comply with study procedures.
6.No use of anti-diabetic or anti-obesity medications for at least 3 months prior to screening.
7.Willing to come for follow up visits for evaluation
8.No significant medical or surgical diseases at the time of screening.
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy, planning pregnancy during the study period or lactation.
2.Use of hormonal contraceptives or hormone replacement therapy within the last 3 months.
3.Diagnosed with severe endocrine disorders e.g., uncontrolled thyroid disease, Cushing syndrome or significant organic pelvic pathology e.g., large fibroids, endometriosis requiring immediate intervention.
4.Known allergy or hypersensitivity to any ingredient in She Care Juice.
5.Use of other treatments pharmacological or herbal known to affect menstrual cycles or hormonal balance within the last month.
6.Significant systemic, immunological, cardiovascular, hepatic, renal or gastrointestinal disorders.
7.Participation in another clinical trial within the last 90 days.
8.Any condition that in the opinion of the investigator would jeopardize the safety of the participant or the integrity of the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in the proportion of participants achieving regular menstrual cycles 21-35 days or documented ovulation.
2.Mean change in modified Ferriman–Gallwey FG Score.
3.Mean change in serum LH, FSH, LH and FSH ratio, and Total Testosterone levels. |
1.Screening, Day 30, Day 60, Day 90.
2.Screening, Day 90.
3.Screening, Day 60, Day 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mean change in the IGA score for acne.
2.Mean change in Weight and BMI.
3.Mean change in fasting insulin, HOMA-IR, HbA1C, lipid profile.
4.To assess the change in quality-of-life score (e.g., using PCOS-Q). |
1.Screening, Day 30, Day 60, Day 90.
2.Screening, Day 30, Day 60, Day 90.
3.Screening,Day 60, Day 90.
4.Screening,Day 30,Day 60, Day 90.
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2025 |
| Date of Study Completion (India) |
20/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a Prospective Open-Label, Single-Arm study with 30 Female participants in the age of 18-45 years to Evaluate the Efficacy and Safety of She Care Juice, in women diagnosed with Polycystic Ovarian Disease. The primary objectives are to evaluate the effect of She Care Juice on menstrual cycle regularity, hirsutism, and key hormonal parameters (LH, FSH, Testosterone) over a 90-day treatment period. Secondary objectives include assessing changes in metabolic markers, anthropometric measurements, acne, and psychological well-being, along with comprehensive safety monitoring. |