| CTRI Number |
CTRI/2025/02/079989 [Registered on: 06/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to test how safe and effective herbal health supplements are for women going through menopause. |
|
Scientific Title of Study
|
A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of Shevari4 On Health and Quality of Life in Premenopausal, Perimenopausal, And Postmenopausal Groups Healthy Women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-CE-CEPHAM-02-0224 version 2.0 dated 20-December-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, New Delhi
South West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena R M |
| Designation |
Head - Medical Affairs |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
RMZ Galleria, 1st floor, Ambedkar Colony, Yelahanka, Bengaluru, Karmataka, India
Bangalore
KARNATAKA
560064
India |
| Phone |
9880902005 |
| Fax |
|
| Email |
veena.rm@cliniexpertsresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kumar |
| Designation |
CEO |
| Affiliation |
CliniExperts Research Services Pvt. Ltd. |
| Address |
Unit No. 325, City Centre Mall, Plot No. 5, Sector 12, Dwarka, New Delhi
South West
DELHI
110075
India |
| Phone |
9999219448 |
| Fax |
|
| Email |
ashwini.kumar@cliniexpertsresearch.com |
|
|
Source of Monetary or Material Support
|
| Cepham, INC
142 Belmont Dr, #14, Somerset, NJ 08873 |
|
|
Primary Sponsor
|
| Name |
Cepham, INC |
| Address |
142 Belmont Dr, #14, Somerset, NJ 08873 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aruna Verma |
LLRM Medical College |
OPD No. 13, Department of Gynecology and Obstetrics
Meerut
UTTAR PRADESH |
9997706487
arunaverma36@gmail.com |
| Dr Rakhi Saxena |
PGH Hospital Pvt Ltd |
Plot No. 89A, Vikasnagar Extn Phase-2, Shukkar Bazar Road, Block B, Uttam Nagar, New Delhi, Delhi-110059
New Delhi
DELHI |
9810911023
saxenaamit244@gmail.com |
| Dr Ruchi Malhotra |
Sehgal Nursing Home |
A6, Panchwati, Opp, Azadpur New Sabzi Mandi, New Delhi-110033
New Delhi
DELHI |
9911917070
ruchidoctor@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee LLRM Medical College |
Approved |
| Institutional Ethics Committee Sehgal Nursing Home |
Approved |
| Institutional Ethics Committee Sehgal Nursing Home |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Premenopausal, Perimenopausal, And Postmenopausal |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo 110mg Capsule made up of Brown Rice Starch |
Dose - 100mg capsule; Frequency - Once a day with evening meal; Route of Administration - Oral; Total Duration - 6 Weeks |
| Intervention |
Shevari 100mg Capsule made from Asparagus racemosus Root Ethanol Extract 5% Shatavarin IV |
Dose - 100mg capsule; Frequency - Once a day with evening meal; Route of Administration - Oral; Total Duration - 6 Weeks |
|
Inclusion Criteria
Modification(s)
|
| Age From |
29.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 29 and 65 years (inclusive).
2. Body Mass Index of 18.5-29.9 (inclusive).
3. Resting systolic blood pressure less than 140 mm Hg and diastolic blood pressure less than 90 mm Hg
4. Resting heart rate less than 90 per minute.
5. Patients attained menopause.
6. Gynaecological examination will be done at the screening.
The pap smear test and sonography will be done to rule out
Gynaecological issues to declare the patient fit at the
discretion of the Principal Investigator
7. Provide voluntarily signed and dated informed consent on paper.
8. The language services in case of non-English will be
provided.
9. Be in good health as determined by medical history and
routine blood chemistries.
10. Willing to duplicate their previous 24-hour diet and fast for 10 hours prior to each visit.
11. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
12. Subject willing and able to comply with the study protocol. |
|
| ExclusionCriteria |
| Details |
1. Current bladder dysfunction.
2. Current bladder neck contracture or urethral structure.
3. Current acute or chronic UTI.
4. History of breast, uterine, ovarian, and cervical cancers.
5. Use of any other herbal medications within the past month.
6. History of radiotherapy.
7. History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
8. History of diabetes or endocrine disorder.
9. History of use of medications or dietary supplements known to confound the study or its endpoints.
10. Use of hormone replacement therapy, oral contraceptives, or other hormone treatment.
11. Women who underwent a hysterectomy.
12. Dietary consumption of soya containing foods.
13. Alcohol consumption (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
14. Current smokers or smoking within the past month.
15. History of hyperparathyroidism or an untreated thyroid condition.
16. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
17. Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, IBS/IBD, diarrheal illnesses, history of
colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU).
18. Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn’s, ulcerative colitis, Lupus, HIV/AIDS, etc.).
19. Known sensitivity to any ingredient in the test formulations as listed in the product label.
20. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
21. Any other conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary objective of the study
To assess the efficacy of SheVari4 in Premenopausal, Perimenopausal, And Postmenopausal syndrome using MRS QoL Survey.
The primary endpoints of the study -
MRS is composed of 11 items and divided into three subscales,
Somatic
Psychological
Urogenital symptoms.
The severity of symptoms varies from none, mild, moderate, and severe. The findings will be subjected to analysis before, after treatment, and follow-up using MRS scale.
|
Day 1, Day 14, Day 28, Day 42, Day 56 and Day 70 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objectives of the study as follows
Change in hormone levels.
Changes in blood biochemistry [comprehensive metabolic panel (CMP), liver function test, complete blood count (CBC)].
Changes in the weight & blood pressure.
To assess the safety & tolerability
The secondary endpoints as follows
Measurement of Thyroxine, TSH, Prolactin, LH, FSH, Serum oestradiol.
Measurement of CBC (HB, RBC Measurements, TC, DC & platelet count), Random blood sugar, Comprehensive metabolic panel (alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, blood urea nitrogen (BUN), creatinine, sodium, potassium, carbon dioxide, chloride, albumin, total protein, glucose, & calcium).
Changes in the weight & blood pressure.
To record any adverse events
|
Day 1, Day 14, Day 28, Day 42, Day 56 & Day 70 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)
|
A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of Shevari4 On Health and Quality of Life in Premenopausal, Perimenopausal, And Postmenopausal Groups Healthy Women. To assess the efficacy of SheVari4 in Premenopausal, Perimenopausal, And Postmenopausal syndrome using MRS QoL Survey. The total planned study duration is 24 to 25 weeks, which includes an initial recruitment period of 3 weeks and follow-up period of 10-12 weeks and 3 weeks for site close out and statistical analysis respectively and 2 weeks for the final report. However, if the planned recruitment is not completed within the initial 6 months (24 to 25 weeks), the recruitment period will be prolonged until the planned recruitment is completed.
|