| CTRI Number |
CTRI/2023/02/049901 [Registered on: 20/02/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Microcore calcium to treat age related or post menopausal Osteoporosis |
|
Scientific Title of Study
|
A Randomized, Open label, Parallel group clinical study comparing the relative bioavailability, safety and efficacy of Microcore NESC® with Calcium carbonate and Calcium citrate malate in osteopenic and osteoporotic patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Krishnagopal Ramamourthy |
| Designation |
Professor & HOD |
| Affiliation |
MGMC&RI |
| Address |
Room no. 1, Department of Orthopaedics,
Mahatma Gandhi medical College and research institute, Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9442244864 |
| Fax |
|
| Email |
krishnagopalr@mgmcri.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Krishnagopal Ramamourthy |
| Designation |
Professor & HOD |
| Affiliation |
MGMC&RI |
| Address |
Room no. 1, Department of Orthopaedics,
Mahatma Gandhi medical College and research institute, Pondicherry
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9442244864 |
| Fax |
|
| Email |
krishnagopalr@mgmcri.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri |
| Designation |
VP Operations |
| Affiliation |
Kai3 |
| Address |
Regus Office Centre Services (Chennai) Pvt Ltd. Olympia Technology Park, Level - 2, Altius Block, No -1, SIDCO Industrial Estate, Chennai
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
Venkat_ani2007@yahoo.Co.in |
|
|
Source of Monetary or Material Support
|
| Microcore Research labs, India. |
|
|
Primary Sponsor
|
| Name |
Microcore Research labs, India. |
| Address |
204-A,Erode - Palani Main Road, Checkumedu, Erode, Tamil Nadu 638115 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DrUmaN |
Mahatma Gandhi Medical College and Research Institute |
Room no.1, Department of Orthopaedics, MGMC&RI, Pondicherry
Pondicherry
PONDICHERRY |
9842329417
numalally@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
| Ki3 Ethics Committee for AYUSH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microcore NESC® Tablet |
Two Tablet orally, daily for 12 weeks |
| Comparator Agent |
Shelcal and CCM |
two Tablet daily, orally for 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients must be in the age group of 45 - 80 years of age.
2. Males or Females: Females must be non-pregnant / non-lactating and practicing adequate birth control measures if not menopausal.
3. Patients should be able to understand and signed the informed consent form after being explained by the investigator. They must be aware of the experimental nature of the therapy, its potential benefits, side effects, risks and benefits.
4. The patients with Osteopenia and Osteoporosis, diagnosed by BMD will be enrolled (Bone mineral density, T score is between -1 and - 2 is called osteopenia and T-score below- 2 indicates osteoporosis).
|
|
| ExclusionCriteria |
| Details |
1. History or presence of significant:
- Cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrinal, immunologic, dermatologic, neurological or psychiatric disease.
2. Alcohol dependence, alcohol abuse or drug abuse within the past one year
3. Ulceration or history of gastric and / or duodenal ulcer.
4. Patients who are allergic to Investigational products
5. HIV positive or immunocompromised individuals
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To monitor the Bone Mineral density (BMD)- Baseline and at 12 weeks
2. Serum Calcium test for relative absorption and bioavailability.
3. Serum Osteocalcin - Baseline and at 12 weeks
4. X-ray at baseline and 12 weeks to understand any fine fracture or cracks in the osteoporotic patient and its healing or regeneration after the course of medication
5. Change from baseline to 12 weeks in knee / body pain intensity measured by Pain VAS Scale (0-100mm)
6. Changes from baseline to 12 weeks in Quality of life-Questionnaires (Short Form Health-36).
|
Baseline and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor for any adverse events |
Baseline upto 12 weeks |
|
|
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)
|
20/02/2023 |
| Date of Study Completion (India) |
01/10/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Ø
The subjects who fulfilled the
inclusion and exclusion criteria will be enrolled in the study.
Ø
60 Participants will be randomized
into 3 groups with 20 in each group.
Ø
Arm 1 - Participants with
Osteopenia and Osteoporosis will take two Tablet daily of Microcore NESC®
orally for 12 weeks
Ø
Arm 2 - Participants with
Osteopenia and Osteoporosis will take two Tablet daily of Shellcal orally for
12 weeks
Ø
Arm 3 - Participants with
Osteopenia and Osteoporosis will take two Tablet daily of CCM orally for 12 weeks |