A prospective, multicenter, open label, clinical study to evaluate efficacy and safety of Vestige Amla capsules in improving Overall health of healthy population.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- •Mean change in Health-related quality of life- SF 36 Questionnaires
研究概览
简要总结
The current clinicalstudy was conducted to evaluate efficacy and safety of Vestige Amla capsules inimproving Overall health of healthy population. Total of 50 subjects wereenrolled in the study. Subjects were advised to consume vestige amla 1 capsule 2 times a day after meals.
Primary objective of this trial was to find out efficacy of Vestige Amla Capsule by evaluatingmean change in Health-related quality of life- SF 36Questionnaires from baseline to day 30.
The SF-36 questionnaire consists of 36 items,which are used to calculate eight subscales: physical functioning (PF), rolephysical (RP), bodily pain (BP), general health (GH), vitality (VT), socialfunctioning (SF), role emotional (RE), and mental health (MH) and isrepresentation of overall health.
Mean value of SF 36 questionnaire at baseline(V1)was 65.0 which increased to 78.7 at visit 2 with mean percentage changerecorded as 21.20% with a statistically significant p Value(P<.0001)
Secondary objective of this trial was to find out safety & tolerability of Vestige AmlaCapsule by evaluating follwoing parameters:
· Mean Change in the Short General HealthQuestionnaire (GHQ 12) score
· Clinical Adverse events occurring duringentire duration of study
The GHQ-12 covers several domains associated with aperson’s psychological well-being and is worded in such a way as to comprisesix positive and six negative items concerning the past few weeks of a person’slife.
Mean value of GeneralHealth Questionnaire (GHQ 12) at baseline(V1) was 26.48 which increased to 32.86at visit 2 with mean percentage change recorded as 24.09% with a statisticallysignificant p Value(P<.0001)
There were no adverse events reported in the study.
From current data set analysis ofthis proof-of-concept study it can be concluded that Vestige Amla Capsule has shown promising results in improving overall health. Studymet its primary and secondary endpoints with significant results. Vestige Amla Capsule are also safe to be used as the study documented noadverse events. However,double blind, placebo controlled studies with larger sample size and increasedduration of consumption can be conducted to reproduce results like current studyin consideration. Its impact on various haematological parameters can also beevaluated in future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Subject is willing and able to give written informed consent.
- •2 Aged 18-65 years of age 3 Subject is willing, able, and likely to comply with all study procedures and restrictions.
排除标准
- •1 Current or 12 months prior to screening severe cardiovascular diseases, including: NYHA Class III or IV chronic heart failure, clinically significant ventricular arrhythmias (ventricular tachycardia, ventricular fibrillation), unstable angina, myocardial infarction, heart and coronary vessel surgery, significant valvular heart disease, uncontrolled arterial hypertension with systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg, pulmonary embolism or deep vein thrombosis.
- •2 Type 1 diabetes mellitus and uncontrolled type 2 diabetes mellitus (HbA1c > 10.5 %, fasting plasma glucose >270 mg/dl at screening or episodes of severe hypoglycemia 1 month prior to screening); 3 Severe diseases of the central nervous system, including seizures in history or conditions that may lead to their development; stroke or transient ischemic attack within 12 months prior to screening; head injuries or loss of consciousness within 12 months prior to screening; a brain tumor.
- •4 Significant uncontrolled concomitant disease, such as neurological, renal, hepatic, endocrine and gastrointestinal which according to the Investigator, could prevent the patient from participating in the study.
- •5 Participation in other clinical studies or administration of investigational products within 4 weeks prior to screening.
- •6 HIV, active viral (hepatitis B and C) or a cirrhotic liver disease in medical history.
- •7 Malignancies within the last 5 years (except for basal cell carcinoma of the skin and cervical cancer in situ that had undergone surgical removal or treatment).
- •8 Drug or alcohol abuse at the time of screening or in the past which, in the opinion of the Investigator, makes the patient unsuitable for participation in the study.
- •9 Pregnant or lactating women or women planning a pregnancy during the clinical study.
- •10 Inability to read or write, unwillingness to understand and follow procedures of study protocol, as well as any other concomitant medical or serious mental conditions that make the patient unfit to participate in the study, limit the legality of obtaining informed consent or can affect patient’s ability to participate in the study.
结局指标
主要结局
•Mean change in Health-related quality of life- SF 36 Questionnaires
时间窗: Day 0 to Day 30
次要结局
- •Mean Change in the Short General Health Questionnaire (GHQ 12) score(•Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study.)