| CTRI Number |
CTRI/2020/03/023713 [Registered on: 02/03/2020] Trial Registered Prospectively |
| Last Modified On: |
|
| 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 assess the improvement of bone mass and safety of the test product |
|
Scientific Title of Study
|
A Randomized, Double Blind, Multicenter, Prospective Clinical
Study to Evaluate the Efficacy, Safety of Test Formulations in Improving Bone
Health in Subjects with Low Bone Mass. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanmay Banerjee |
| Designation |
Principal Investigator |
| Affiliation |
Medistar Hospital |
| Address |
Department of Orthopaedics
Medistar Hospital
Vadodara 390010, Gujarat, India
Vadodara
GUJARAT
390010
India |
| Phone |
|
| Fax |
|
| Email |
tanmay_ortho@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9, 1st Floor, Mythri Legacy, Chelekere Main Road, kalyan Nagar, Bangalore 560043
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9, 1st Floor, Mythri Legacy, Chelekere Main Road, kalyan Nagar, Bangalore 560043
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Centre, Peenya Industrial Area, No. 3, 1st Main, 1st Phase , Bangalore – 560 058, |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial Area, No. 3, 1st Main, 1st Phase , Bangalore – 560 058, |
| Type of Sponsor |
Other [FMCG] |
|
|
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 Tanmay Banerjee |
Medistar Hospital |
Department of Orthopaedics
GIDC Vadsar Rd, Adjoining Vadsar Flyover,
Vadodara
GUJARAT |
798415265
tanmay_ortho@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Anand Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Low bone mass |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Oral Administration of 500 mg capsule once a day for 6 months. |
| Intervention |
Test Product 1 |
Oral Administration of 500 mg capsule containing 125mg herbal extract once a day for 6 months |
| Intervention |
Test Product 2 |
Oral Administration of 500mg capsule containing 250mg of herbal extract once a day for 6 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with low bone mass (BMD, T- score of -1 to -2.5 SD)
2. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form |
|
| ExclusionCriteria |
| Details |
1. History of any illness affecting bone metabolism like renal failure, hepatic failure, active malignancy,
hyperthyroidism or hyper parathyroidism
2. Pregnant or lactating women.
3. Female patient of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study treatment and for 4 weeks after the end of treatment.
4. Subjects with
Alkaline phosphatase more than twice the upper limit of normal, Liver disease (SGOT or SGPT more than twice the upper limit of normal),Kidney disease (creatinine >2.0 mg/dL)
Hypercalcemia (calcium >10.5 mg/dL)
5. Uncontrolled chronic disorders that could affect bone metabolism (liver disease, alcoholism, primary hyperparathyroidism, or malignancy)
6. Pharmacotherapy for osteoporosis (except calcium or vitamin D) in the previous 3 months
7. Injection of an agent for osteoporosis in the previous 6 months
8. Systemic administration of an agent that may affect calcium metabolism in bone, such as a systemic corticosteroid or diuretic, for more than 6 months (subjects who have not received forbidden drugs except contraceptive injections within the previous 3 months before screening may be eligible to
participate)
9. Metabolic bone diseases other than osteoporosis
10. A mental disorder likely to affect compliance with the requirements of the trial
11. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study
12. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Bone mass, Bone Resorption and bone formation markers |
Day 0, Day 90, Day 180 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in Joint Health and Inflammatory markers |
Day 0, Day 90, Day 180 |
| Changes in Serum levels of calcium, phosphorus and vitamin D |
Day 0, Day 90, Day 180 |
| Changes in Questionnaire based Assessments |
Day 0, Day 90, Day 180 |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
02/03/2020 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
"None Yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a double blind, randomized (1:1:1), placebo controlled, parallel group, three-arm study. Subjects meeting all inclusion and no exclusion criteria after signing a written informed consent will be enrolled in the study. After passing the eligibility criteria, subjects will be randomized into 3 treatment arms to receive Test Product 1, Test Product 2 or Placebo. The investigation products (IPs) will be administered once a day (single dose of randomized IP half an hour after breakfast in the morning) for 6 months. The efficacy of the IP’s will be assessed by dual-energy X-ray absorptiometry (DEXA) scan, and based on markers for bone formation , bone resorption ,joint health and Inflammation.Serum levels of calcium, phosphorus and vitamin D also will be assessed. , Questionnaire based assessment will be used to assess the impact on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Quality of life will be assessed by SF-12 questionnaire. The safety and tolerability of the IP’s will be assessed by evaluation of incidences of adverse events reported |