| CTRI Number |
CTRI/2025/03/083217 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to asses the effect of CL22205 on bone mineral density and menopausal symptoms in women |
|
Scientific Title of Study
|
The effect of CL22205 on bone mineral density and menopausal symptoms in women: A randomized, double-blind, placebo controlled clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EB/MS/CL22205/24 Protocol Version 01 28-Oct-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arti Dibya |
| Designation |
MBBS, MS DGO |
| Affiliation |
Vastalya Hospital and multispecialty Centre |
| Address |
Vastalya Hospital and multispecialty center S-2/656 C/4A,Sikraul,Varanasi, UttarPradesh 221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9648418967 |
| Fax |
|
| Email |
anudibya@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varuni B G |
| Designation |
Consultant |
| Affiliation |
Eetho Brands Inc (DBA: Dose) |
| Address |
Department of Research Clinical division Room No.01 Ground Floor 164 3rd Cross Hanumanth Nagar Bangalore
Bangalore
KARNATAKA
560019
India |
| Phone |
6366292424 |
| Fax |
|
| Email |
vbgresearch24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa K |
| Designation |
Research Associate |
| Affiliation |
Eetho Brands Inc (DBA: Dose) |
| Address |
Department of Research Clinical division Room No.G 3 Ground Floor 742 Krishnanadi road 6th Main Sreenagar.
Bangalore
KARNATAKA
560050
India |
| Phone |
9611934557 |
| Fax |
|
| Email |
shilpakkshilpakk389@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eetho Brands Inc (DBA Dose) 51 NE 24th St Suite 206 Miami FL 33137 |
|
|
Primary Sponsor
|
| Name |
Eetho Brands Inc |
| Address |
Eetho Brands Inc (DBA Dose) 51 NE 24th St Suite 206 Miami FL 33137 |
| Type of Sponsor |
Other [nutraceuticals 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 Arti Dibya |
Vastalya Hospital and multispecialty Centre |
Vatsalya Hospital Multispeciality Center, S-2/656,C4A, Sikraul,Varanasi
u.P 221002
Varanasi
UTTAR PRADESH |
9648418967
anudibya@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| vatsalya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menopause symptoms |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: CL22205, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 200(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Years, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | | One capsule daily after breakfast with water for 360 days |
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Healthy females aged between 55 and 65 years with a Body mass index (BMI) ofapproximately 24 and 29 kg/m2.
2.Women with menopausal symptoms (modified Kupperman index scores 15-29), absenceof menstrual cycle for past 12-months; follicle-stimulating hormone (FSH) more than 30mIU/mL; estradiol less than 30 pg/mL.
3.Subjects who are under standard supplementation of Vitamin D3 (cholecalciferol) andcalcium carbonate.
4.Subjects with osteopenia (T score of spine between -1 and -2.5 in DEXA).
5.Must also be experiencing at least two symptoms of menopause, such as sleepdisturbances, mood changes, fatigue and lack of energy, changes in sexual function,urinary changes, weight gain, or vaginal changes
6.Subject understands the study procedures and provides signed informed consent toparticipate in the study.
7.Normal vital signs, including electrocardiogram (ECG) and laboratory evaluations(including clinical biochemistry, haematology, lipid profile, thyroid profile and completeurinalysis) within the reference range for the testing laboratory or the results are deemednot clinically significant for inclusion into this study by the investigator. |
|
| ExclusionCriteria |
| Details |
1.Consumption of functional food or supplement that modifies body composition, during or6 months prior to the study.
2.History of cerebrovascular disease, thrombo-embolic disorders, heart attack, or angina atany time or thrombophlebitis within the last 5 years.
3 Subjects on anti-coagulant or anti-platelet drugs on a daily basis for any conditions.
4.Presence of chronic diseases that prevent the performance of a physical exercise program(disabling arthropathies, moderate / severe chronic lung disease, arrhythmias, etc.)
5.High alcohol intake (more than 2 standard drinks per day), or recreational drugs (such ascocaine, methamphetamine, marijuana, etc.) or psychiatric drug users.
6.Smokers or tobacco users.
7.Inability to understand informed consent.
8.Serious or terminal illnesses.
9.Fasting blood glucose level more than 125 mg/dl.
10.Subjects with a high blood pressure at screening (systolic blood pressure more or equalto 140 mmHg or diastolic blood pressure more or equal to 90 mmHg).
11. Subjects who had any hormonal therapy, metformin or any other herbal products in the past 3 months.
12.Hypothyroidism, hyperthyroidism, hyperprolactinemia, Cushings syndrome and congenital adrenal hyperplasia, following a special diet for the past 3 months.
13.Taking drugs affecting insulin sensitivity or lipid and hormonal profiles, including glucocorticoids, ovulation-stimulating drugs, anti-obesity, anti-diabetes, anti-hypertensive, anti-estrogenic, anti-androgenic during the last 3 months (except the usual drugs of the subjects).
14. Active gall bladder disease, gynaecological (including hysterectomy) or breast surgery in the last 6 months.
15. Subjects who are being treated for liver cancer or cirrhosis, chronic renal failure, congestive heart failure.
16. Subjects with a systemic disease including tuberculosis, leucosis, collagenosis, multiple sclerosis or other autoimmune diseases.
17. History of breast, endometrial, other gynaecological cancer at any time or other cancer within the last 5 years.
18.History of hypersensitivity reactions attributed to investigational product (IP) or its components or related products.
19.History of positive hepatitis screening including Hepatitis B surface antigen or Hepatitis C virus (HCV) antibodies or subjects with human immunodeficiency virus (HIV) and or syphilis.
20. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol.
21.Participated in a clinical study with an investigational drug or biologic within the last 30 days.
22. Any condition that in opinion of the investigator, does not justify the subjects participation in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bone Mineral density (BMD) (g/cm2) of Lumbar spine (L1-L4)
|
Screening, Day 180, Day 360 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to the end of the study period in Scores ofmodified Kupperman index (mKI) |
Screening, Baseline, Day 90,Day 180,Day 360 |
| Change from baseline to the end of the study period in Lean bodymass through DEXA |
Screening,Day 180, Day 360 |
| Change from baseline to the end of the study period in Hand grip-strength |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in ChalderFatigue Scale (CFS) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Profile ofMood States (POMS-SF) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in FemaleSexual Function Index (FSFI) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in PittsburghSleep Quality Index (PSQI) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in MenopauseSymptoms Severity Inventory (MSSI-38) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Mini CogQuestionnaire (Cognitive function) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Scores ofsubjective self-assessment on hair quality |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Nail qualityrelated questionnaire (NailQoL) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period inGastrointestinal symptoms questionnaire (GIS) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in PerceivedStress Scale (PSS-10) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Visualassessment of skin wrinkles |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Core LowerUrinary Tract Symptom score (CLSS) |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Subjects self-assessment of skin Questionnaire |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Skin hydration using moisture meter |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Vaginal pH & dryness |
Baseline, Day 90, Day 180,Day 360 |
| Change from baseline to the end of the study period in Bone specific ALP, Osteoprotegerin, and Osteocalcin in serum |
Baseline, Day 360 |
| Change from baseline to the end of the study period in Serum cortisol |
Baseline, Day 360 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
31/03/2025 |
| 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="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The Purpose of the study is to evaluate the effect of CL22205 on bone mineral density and menopausal symptoms in women, subject will receive either CL22205 200mg or placebo orally one capsule per day after breakfast for 360 days. |