An Open Labeled Single Group Proof of Concept Study to Evaluate the Efficacy & Safety of Myostaal SB Tablets in Participants Suffering with Osteopenia
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
Participant attending OPDof the hospital and satisfying the selection criteria will be selected. AllParticipant’s who voluntarily agree to participate and provide written informedconsent for participation will be recruited in the study. During the studyperiod, there will be 8 visits including the Screening visit , duration of drugis 180 days
Medical history,physical examination, bone mineral density test (DXA scan) of the subject willbe done. Blood will be collected for hematological and biochemicalinvestigations (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. Studymedication will be dispensed to the subject for 30 days. Ayurvedic symptomscore/Prakriti, history of concomitant medication, adverse events if any,compliance to treatment will be assessed and documented inthe CRF.
Test medication
The test drug will bein the form of solid oral formulation. It is given in the dose of one tablets thrice daily for 6 months.
The main ingredientsare: *Kukkutandatvak Bhasma, Shatavari,*Asthisamhruta
On visit 2 (day 0) andevery 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 emptycontainer to check for compliance. The number of unused strips will becalculated.If theparticipant’s compliance to study drug is less than 70% or does not take for 2weeks continuously will be withdrawn from the study.Participant comingto the OPD will be interrogated by the study investigatorabout compliance to the study drug, adverse effects. Any concurrent illness and itstherapy will be noted by investigator.A complete physical examination will bedone by the investigator. Ayurvedicsymptom score/Prakriti score will be filled in by theinvestigator.If the participant is female and is able to have children and notattained menopause, she will undergo a urine pregnancy test.The efficacy and safety data willbe analyzed using ‘Intention to Treat’ analysis. Interim analysis will becarried out at the end of 6 months an to assess the efficacy of the studymedication
Data will be analysed using SPSS version 21 software.Descriptive statistics will beassessed.Data will be expressed in percentages and Mean + SD.Normalityof data will be assessed using Wilk Shapiro test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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
时间窗: •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
次要结局
- 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)