| CTRI Number |
CTRI/2025/03/082025 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
07/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical trail on Post Menopausal Syndrome |
|
Scientific Title of Study
|
A prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of VITEX extract in subjects suffering with Post Menopausal Syndrome.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/PM/VITEX/2024 Version No 1.0 Dated 16 Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd. |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
Bangalore
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd. |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd. |
| Address |
Radiant Research Services Pvt Ltd.
NO.99/A, 8th Main Road, 3rd Phase,
Peenya Industrial Area, Bengaluru-560 068
Karnataka, India.
KARNATAKA
560058
India |
| Phone |
9880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ingex Botanicals Private Limited
No.508, Medini, 60 ft road
F Block, Sahakaranagar, Bengaluru-560092,
Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Ingex Botanicals Private Limited |
| Address |
No.508, Medini, 60 ft road
F Block, Sahakaranagar, Bengaluru-560092,
Karnataka, India. |
| Type of Sponsor |
Other [ [Nutraceutical supplement company]] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Bio Actives Japan KK |
4-1-1, BAJ Bldg., Minami-Nagasaki, Toshima-Ku, Tokyo, JAPAN -171-0052 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shubarani BAMS MD |
Sri Venkateshwara Hospital |
Site No 1, SKY HEIGHTS,2, Sarjapura
Attibele Road, Bangalore,
Karnataka 562107
Bangalore
KARNATAKA |
9449453674
dr.shubharani111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Women who are in the stage of Post menopausal syndrome |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Starch |
Dose:300mg Dosing frequency: Capsules Duration: One capsule orally in the morning after breakfast upto 60 days |
| Intervention |
VITEX
extract |
Dose:300mg Dosing frequency: Capsules Duration:One capsule
orally in the morning after
breakfast upto 60 days. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Menopausal transition (if menstruation has not occurred for more than
3 months).
2.Those with FSH (Follicle stimulating hormone) exceeding 30 mIU/mL.
3.Women aged 40 to 65 who are in menopause (more than 1 year after
the last menstruation).
4.Those with a KI (Kupperman Index) score of 25 or higher.
5.Those who complain of clinical menopausal symptoms even if their KI
score is less than 25. |
|
| ExclusionCriteria |
| Details |
Drug use
1.Women who have used hormone preparations such as female hormones or similar hormone preparations plant extracts etc within the past 3 months
2 Drug addicts
3 Those who have used thyroid hormone preparations Clonidine anticoagulants or antithrombotic drug Aspirin Warfarin Clopidogrel etc within the past 3 months
4 Those who have taken medicines related to female menopause or health functional foods within the past 1 month
5 Those who are taking or administering osteoporosis treatment drugs such as bisphosphonates
Disease status
6 Those with a body mass index(BMI exceeding 30 kg per m 2
7 Those with a history of endometrial hyperplasia uterine cancer endometrial cancer cervical cancer breast cancer breast disease or cancer related to sex hormones
8 Those who have undergone hysterectomy
9 Women who have had severe migraines thromboembolism cerebrovascular disease myocardial infarction unstable angina within the past year or have had coronary angioplasty
10 Women with mental illnesses such as depression or anxiety disorder or who are currently taking antidepressants or other psychotropic drugs
11 Women with undiagnosed abnormal uterine bleeding 1 year after menopause
12 Those with uncontrolled hypertension SBP 140 mmHg or DBP 90 mmHg
13.Those with uncontrolled diabetes HbA1C 7 0
14 Those with thyroid-stimulating hormone TSH levels above those outside the normal range
15 Those with ALT and AST levels 3 times higher than the upper limit of normal
16 Those with eGFR less than 60 mL min1.73m 2
17 Those with endometrial thickness 7 mm
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints:
1.Changes in MENQOL
2.Changes in MRS score
3.Changes in QOL questionnaire |
Day 0, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Endpoints
1.Changes in Reduction in hot flushes & Night sweats
2.Changes in Pain score (Muscle & Joint)
3.Changes in Anxiety & Stress levels (Cortisol)
4.Changes in Biomarkers (LH, Estradiol & FSH)
5.Changes in Thyroid Profile (T3, T4 & TSH)
6.Changes in RA Factor
7.To assess the safety of the product through safety assessments(Screening Visit and day 60). |
Day 0, Day 30 and Day 60. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/03/2025 |
| Date of Study Completion (India) |
15/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Postmenopausal Syndrome (PMS) refers to a collection of symptoms occurring after the cessation of menstruation, affecting women’s physical, emotional, and mental well-being. With aging populations globally, effective management of PMS has become a public health priority.Menopause symptoms severely reduce the quality of life of women worldwide, with up to 80% of women experiencing symptoms. It is estimated that by 2030, the groups of post-menopausal women will reach 1.2 billion globally (Gold et al. 2006). During menopause, women undergo biological, social, and psychological changes and are sensitive to stressors, especially anxiety and depression. Decreased estrogen in postmenopausal women causes mood swings, especially depression and anxiety. Menopausal symptoms have remarkable negative effects on women’s quality of life, justifying the need to assess various therapeutic options. Vitex is a genus belonging to the sage family, Lamiaceae, and comprises around 250 species. Commonly referred to as the chaste tree or chastetree, the term often specifically denotes Agnus castus but is also applied to other species. Native to regions of middle Asia and the Mediterranean, Vitex has a long history of use in treating various menstrual issues. Historically, it was believed to reduce sexual desire, which is why it is called the "chaste tree," with “agnus” meaning "chaste" in Greek and “castus” carrying the same meaning in Latin. The chaste tree (Vitex agnus-castus) contains a diverse range of chemical components, including Flavonoids, Glycosides, Organic acids, Alkaloids, Essential oils, Diterpenoids and Sterols. Although its active ingredient has not been identified, the herb’s bioactive constituents, particularly flavonoids and diterpenes, contribute to its therapeutic properties. Derived from the fruit of Vitex agnus castus (Chasteberry). Extracts of chaste tree are prepared from the leaves, tender stems, flowers, and seeds and provided as syrup, elixir, powder, or a component of a multi ingredient dietary supplement. Also available in various forms: capsules, tablets, supplements. Traditionally used for hormonal balance, menstrual issues, and menopausal symptoms May help with PMS symptoms, Menstrual irregularities, Fertility issues and Menopausal symptoms (hot flashes, mood swings). |