| CTRI Number |
CTRI/2025/05/086280 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To understand the effects of Shatavari root extract capsules in women with menopausal symptoms |
|
Scientific Title of Study
|
A Multicenter, Randomized, Double Blind, placebo controlled, Parallel study to evaluate the effects of Shatavari root extract in the management of menopausal symptoms associated with Peri and Post Menopausal Women. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| iVRS-CD-25-014, Version 01, Dated: 25 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Farzana Mustaq Ahmed |
| Designation |
Principal Investigator |
| Affiliation |
Santhosh Hospital |
| Address |
Room No. 3, 3rd Floor, Gynecology Department, OPD Building, Santhosh Hospital, #6/1, Promenade Road, Behind Coles Park, Frazer Town,
Bangalore
KARNATAKA
560005
India |
| Phone |
9845084911 |
| Fax |
|
| Email |
guideline9@hotmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Nehru Sai Suresh |
| Designation |
Associate Manager – R&D |
| Affiliation |
India Glycols Limited |
| Address |
India Glycols Limited,
Plot No:2-5, Pharmacity, Selaqui, Dehradun – 248011 (Regd Office at A-1 Industrial Area, Bazpur road, Kashipur-, Uttarakhand, India)
Udham Singh Nagar
UTTARANCHAL
244713
India |
| Phone |
9553659653 |
| Fax |
|
| Email |
nehru.s.suresh@indiaglycols.com |
|
Details of Contact Person
Public Query
|
| Name |
T Vijaya Bhaskar |
| Designation |
Senior Director Clinical Development |
| Affiliation |
Invitro Research Solutions Pvt. Ltd., |
| Address |
Clinical Development Department, Room No. 301, 3rd Floor, No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal,
Bangalore
KARNATAKA
560092
India |
| Phone |
6366575282 |
| Fax |
|
| Email |
vijay@ivrs.org.in |
|
|
Source of Monetary or Material Support
|
| India Glycols Limited, Plot No 3 & 4, Pharmacity Selaqui, Dehradun, Uttarakhand 248197 |
|
|
Primary Sponsor
|
| Name |
India Glycols Limited |
| Address |
Plot No 3 & 4, Pharmacity Selaqui, Dehradun, Uttarakhand 248197 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| InVitro Research Pvt Ltd |
No. 22 & 23, Kodigehalli Main Road, Sahakar Nagar Post, Hebbal, Bangalore-560092, Karnataka |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farzana Mushtaq Ahmed |
Santhosh Hospital |
Room No. 3, 3rd Floor, Gynaecology Department, OPD Building, Santhosh Hospital, #6/1, Promenade Road, Behind Coles Park, Frazer Town, Bengaluru-560055
Bangalore
KARNATAKA |
9845084911
guideline9@hotmail.com |
| Dr Narayanaswamy V |
Vagus Super Specialty Hospital, |
Room No. 1, Ground Floor, Gynaecology Department, OPD Building, Vagus Super Specialty Hospital, #6,7,8, 18th Cross, 4th Main, Malleshwaram, Bengaluru-560055
Bangalore
KARNATAKA |
9448053952
drnarayanavagus@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Santhosh Institutional Ethics Committee |
Approved |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N951||Menopausal and female climactericstates, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo Capsules |
One Placebo capsule daily over 56 days of dosing period.
|
| Intervention |
Shatavari root extract capsules |
One Shatavari root extract capsule daily over 56 days of dosing period. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1. Sexually active females of age between 45 and 55 years (both inclusive).
2. Participants with menopause symptoms, defined as a score of greater or equal to 9 to lesser than equal to 16 in the Menopausal Rating Scale (MRS) at screening (includes both peri-menopausal and post-menopausal women).
3. Perimenopausal and postmenopausal women who are experiencing bothersome VMS (Vasomotor Symptoms). Perimenopause is defined as amenorrhea for greater than 60 days in the past 12 months; post menopause is defined as being without a menstrual cycle due to spontaneous reasons for the preceding 12 months.
4. Female participants who are having more than 10 Hot Flushes events per week for past 5 weeks.
5. Participants who experience at least two symptoms of menopause, such as sleep disturbances, mood changes, fatigue and lack of energy, changes in sexual function, urinary changes, weight gain, or vaginal changes.
6. Participants with BMI between 18 and 40 kg/m2 (both inclusive) at the time of screening.
7. Participants who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual lifestyle throughout the trial period.
8. Participants willing to refrain from taking any medications or preparations for addressing menopause symptoms, stress or anxiety or mood or sleep (herbal, dietary supplements, homeopathic preparations, etc.) during the study.
9. Participants who do not have any substance dependence or withdrawal (tobacco, alcohol, medications etc.,).
10. Participants willing to refrain from consuming caffeine and caffeine-containing products 12 hours prior to assessment days.
11. Participants willing to refrain from vigorous physical activity 12 hours prior to assessment days.
12. Participants willing to provide written consent.
13. Participants willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required study period visits, comply with therapy prohibitions, (as mentioned in criteria 8 and criteria 10) and be able to complete the study. |
|
| ExclusionCriteria |
| Details |
1. Female participants who are pregnant or who is planning for a pregnancy (either naturally with medical assistance or by invitro methods) or breastfeeding.
2. Participants having hypersensitivity or history of allergy to the study product or any other herbal ingredients/nutraceutical products.
3. Participants with evidence of malignancy or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
4. Female participants who have undergone surgical menopause.
5. Participants suffering from a metabolic disorder- confirmed through known history (uncontrolled diabetes, uncontrolled thyroid condition) and/or from any severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from any disease found to be interfering with the conduct of the study by the investigator.
6. Participants with a psychiatric diagnosis including anxiety or depression.
7. Participants with sleep disturbances and who are on prescription/over the counter/herbal/nutraceutical or any other system of therapy for sleep related concerns.
8. Participants with history of using hormonal therapy for menopause.
9. Participants with uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg) at screening.
10. Participants who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, centrally acting corticosteroids, opioid pain relievers, hypnotics, and/or prescribed sleep medications.
11. Participants who have excessive habitual caffeine consumption (greater than 300 mg caffeine/day or greater or equal to 3 cups of caffeinated coffee/day) throughout the study period.
12. Participants who are consuming or planning to consume soy/estrogenic foods like soybean oil or other estrogenic diet supplements.
13. Participants with a history of drug and /or alcohol abuse at the time of screening.
14. Participants who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
15. Investigator is uncertain about the participant’s capability or willingness to comply with the protocol requirements. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in scores of hot flushes from Menopause Rating Scale (MRS) assessment.
2. Change in hot flush frequency based on hot flush diary.
3. Change in climacteric symptom scores based on Menopause Rating Scale (MRS) assessment.
|
1. from baseline to end of the study.
2. from baseline to end of the study.
3. from baseline to end of the study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in perceived stress levels (Perceived stress scale – PSS 10).
2. Change in Menopause specific quality of Life (MENQOL-I).
3. Change in improvement of the mood (POMS-2- Profile of Mood states)
4. Change in Sleep Quality Index.
5. Change in hormonal balance (Serum Estradiol) |
1. from baseline to end of the study.
2. from baseline to end of the study.
3. from baseline to end of the study.
4. from baseline to end of the study.
5. from baseline to end of the study.
|
|
|
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)
|
20/05/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 menopause transition is usually a gradual process occurring over many years, caused by the cessation of ovarian reproductive function, resulting in the end of menstrual bleeding. In the peri-menopause, ovarian function and therefore the production of the hormones estrogen, progesterone and testosterone can fluctuate greatly, leading to a wide variety of symptoms, affecting multiple organ systems. During perimenopause and menopause, hot flushes and night sweats are common, as well as headaches and joint pains may become more frequent. Women become more irritable and emotionally volatile, and their ability to concentrate deteriorates. These symptoms can be of different intensity and frequency. The test product is a standardized herbal root extract of Shatavari. This clinical study was conducted to
assess the safety and efficacy of the extract in the management of menopausal symptoms in humans. Shatavari (Asparagus racemosus Willd.), traditionally used in Ayurveda for its balancing effect on Pitta
and Vata doshas. Shatavari is rich in phytoestrogens-plant-derived compounds with estrogen-like
activity which may help relieve menopausal symptoms. This 8-week clinical trial will examine the effects of a Shatavari root extract on climacteric symptoms chiefly on hot flushes and also on night sweats, mood swings, anxiety, fatigue, and brain fog. Participants will be instructed to consume the product daily and complete study-specific assessments at Baseline, Week 2, Week 4, Week 6 and Week 8 |