| CTRI Number |
CTRI/2021/06/034249 [Registered on: 15/06/2021] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Myostaal SB Tablets in Participants Suffering with Osteopenia |
|
Scientific Title of Study
|
An Open Labeled Single Group Proof of Concept Study to Evaluate the Efficacy & Safety of Myostaal SB Tablets in Participants Suffering with Osteopenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrMrudul Chitrakar |
| Designation |
Associate professor |
| Affiliation |
D.Y.Patil UniversitySchool of Ayurveda |
| Address |
D.Y.Patil University School of Ayurveda,Sector-7,Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
9920071114 |
| Fax |
|
| Email |
mrudulmlonkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMrudul Chitrakar |
| Designation |
Associate professor |
| Affiliation |
D.Y.Patil UniversitySchool of Ayurveda |
| Address |
D.Y.Patil University School of Ayurveda,Sector-7,Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
9920071114 |
| Fax |
|
| Email |
mrudulmlonkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Kumar Harit |
| Designation |
Dean,Professor |
| Affiliation |
D.Y.Patil UniversitySchool of Ayurveda |
| Address |
D.Y.Patil University School of Ayurveda,Sector-7,Nerul
Thane
MAHARASHTRA
400706
India |
| Phone |
9322217607 |
| Fax |
|
| Email |
maheshkumar.harit@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| The study drug will be provided by M/S Solumiks Herbaceuticals Limited. The study drug is manufactured according to GMP standards by Om Pharmaceuticals Limited |
|
|
Primary Sponsor
|
| Name |
Solumiks Herbaceuticals Limited |
| Address |
135, Nanubhai Desai Road, Khetwadi, Girgaon, Mumbai- 400 004 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrMrudul YChitrakar |
D.Y.Patil Ayurved hospital |
D.Y.Patil University School of Ayurveda,OPD no.6
Sector-5,Nerul,Navi Mumbai
Thane
MAHARASHTRA |
9920071114
mrudulmlonkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, D. Y. Patil Deemed to be University School of Ayurveda, Nerul, Navi Mumba |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M86-M90||Other osteopathies. Ayurveda Condition: suffering from Osteopenia with BMD T- score between (-1 to -2.5), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Myostaal SB |
one tablet thrice daily for 180 days |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Participant of either sex in the age group of 40-75 years (both years inclusive).
2. Participant’s suffering from Osteopenia with BMD T- score between (-1 to -2.5)
3. Participant’s with a history of fractures that may have occurred with a minor injury or fall.
4. Participant’s willing to give written informed consent.
5. Participant’s willing to follow up.
|
|
| ExclusionCriteria |
| Details |
1. Participant’s consuming any drug known to affect bone metabolism e.g. SERMs, bisphosphonates, calcitonin, Vit.D (more than 60,000 units), methotrexate, anti-epileptic drugs, loop diuretics, corticosteroids (more than 5mg/day of prednisolone or equivalent) etc for more than 3 months.
2. Participant’s with Serum Ca2+ level is either < 2.2 or > 2.6 mmol/L (< 9 or >10.5 mg/dL)
3. Participant suffering from Osteomalacia, Tumor, Osteonecrosis, osteomyelitis or any other bone-softening metabolic disorders.
4. Participant’s suffering from congenital disorders (Dysosteogenesis and Marfan’s Syndrome)
5. Participant’s with documented history of Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfecta or Renal osteodystrophy, Malabsorption syndrome
6. Participant’s with documented history of endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushing‘s syndrome)
7. Participant’s with history of any Organ transplantation
8. Participant’s who are immobilized since > 6 weeks
9. Participant’s who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, heart failure Stroke or Severe Arrhythmia in the last 6 months.
10. Participant’s with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
11. Participant’s who may require treatment of oral and/or injectable steroids or surgical intervention during the course of study duration.
12. Participant’s with history of clinically-active renal, hepatic or peptic ulcer disease
13. History of life threatening cardiovascular and /or neurological event in the past one year.
14. Participant’s having any severe active infectious disease requiring hospitalization.
15. Participant’s who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study
16. Participant’s with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.
17. Participant’s with hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as Sr. creatinine > 1.2mg/dl).
18. Participant’s with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients)
19. Participant’s with history of alcohol or drug abuse.
20. Pregnant and lactating women.
21. Participant’s receiving any other treatment for Osteopenia other than vitamin supplements.
22. Participant who has taken study drug or any herbal medication in the past 4 weeks.
23. Participant with history of severe allergy or anaphylactic reaction.
24. Participant participating in another investigational drug trial in the previous 30 days.
25. Participant’s who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
26. Participant with documented history of positive screening result for hepatitis B and/or Hepatitis C virus.
27. Participant with documented history of HIV or any immune deficient conditions.
28. Any other condition which the P.I. thinks may jeopardize the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Myostaal SB Tablets in Participant’s suffering from osteopenia in terms of change in the BMD score before and after intervention |
•To evaluate efficacy of Myostaal SB Tablets in Participant’s suffering from osteopenia in terms of change in the BMD score at baseline and after 6 months at the end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the change in the Ayurvedic symptom scores before and after intervention
2. To assess the change in the biochemical markers (vitamin D, Alkaline phosphatase level(ALP) PTH (Parathyroid harmone)levels before and after intervention
3. To assess the safety of tablet Myostaal SB with respect to hematological parameters like Hb, CBC, SGOT, SGPT, BUN, S. Creatinine
|
day 0, day 90 and day 180 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/06/2021 |
| Date of Study Completion (India) |
11/06/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/11/2023 |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
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
|
Participant attending OPD
of the hospital and satisfying the selection criteria will be selected. All
Participant’s who voluntarily agree to participate and provide written informed
consent for participation will be recruited in the study. During the study
period, there will be 8 visits including the Screening visit , duration of drug
is 180 days
Medical history,
physical examination, bone mineral density test (DXA scan) of the subject will
be done. Blood will be collected for hematological and biochemical
investigations (Hb, CBC, SGOT, SGPT, Sr. Creatinine, BUN,Sr.PTH,ALP).
On each follow-up Visit
[Visit 3 (Day 30 ± 7), Visit 4 (Day 60 ± 7), Visit 5 (Day 90 ±
7), Visit 6 (Day 120 ± 7), Visit 7 (Day 150 ± 7)]
physical examination will be done and vital signs will be recorded. Study
medication will be dispensed to the subject for 30 days. Ayurvedic symptom
score/Prakriti, history of concomitant medication, adverse events if any,
compliance to treatment will be assessed and documented in
the CRF.
Test medication
The test drug will be
in the form of solid oral formulation. It is given in the dose of one tablets thrice daily for 6 months.
The main ingredients
are: Kukkutandatvak Bhasma, Shatavari, Asthisamhruta
On visit 2 (day 0) and
every follow up visit (3,4,5,6,7), participant’s will be given Myostaal SB Tablets for 37 days and will be asked to return the empty
container to check for compliance. The number of unused strips will be
calculated.If the
participant’s compliance to study drug is less than 70% or does not take for 2
weeks continuously will be withdrawn from the study.Participant coming
to the OPD will be interrogated by the study investigator
about compliance to the study drug, adverse effects. Any concurrent illness and its
therapy will be noted by investigator.A complete physical examination will be
done by the investigator. Ayurvedic
symptom score/Prakriti score will be filled in by the
investigator.If the participant is female and is able to have children and not
attained menopause, she will undergo a urine pregnancy test.The efficacy and safety data will
be analyzed using ‘Intention to Treat’ analysis. Interim analysis will be
carried out at the end of 6 months an to assess the efficacy of the study
medication
Data will be analysed using SPSS version 21 software.Descriptive statistics will be
assessed.Data will be expressed in percentages and Mean + SD.Normality
of data will be assessed using Wilk Shapiro test.
|