A Comprehensive Study of Saushthi Candy and Vati on Postmenopausal Women
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Objective Parameters such as
研究概览
简要总结
The present study is entitled - A Comprehensive study of Saushthi Candy and Vati on Postmenopausal women. The study contains a literary review of the ingredients used in the preparation of products, analytical study of components, acute toxicity study and clinical study. After the study, the outcomes will be published in Indexed journals.
Purpose of the trial - To evaluate the efficacy of Saushthi Candy and Vati in the management of Calcium deficiency/hypocalcaemia in postmenopausal women. This trial will develop clinical proof for Saushthi Candy and Vati as a herbo-mineral calcium supplement in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Females of age 45-70 years who have attained menopause.
- •Patients having serum calcium level less than 8.9 mg/dl on examination.
排除标准
- •Patients with evidence of malignancy.
- •Patients with serum calcium level more than or equal to 8.9 mg/dl.
- •Patients suffering from any major diseases (eg.
- •Diabetes Mellitus, Hypertension, Coronary Artery Disease, Stroke, Hypothyroidism or Hyperthyroidism, Hypoparathyroidism or Hyperparathyroidism, Renal or Hepatic Disease, or Malignant or Metabolic Bone Disease).
- •Patients receiving hormone, corticosteroid therapy and on long term medication.
结局指标
主要结局
Objective Parameters such as
时间窗: 2 months
Serum Calcium, Serum Albumin, Serum Alkaline Phosphatase, Urine Calcium, Liver Function Test (LFT), Renal Function Test (RFT) will be assessed.
时间窗: 2 months
次要结局
- Subjective parameters such as Paresthesia, Muscle Spasm, Cramp, Tetany, Circumoral Numbness, Seizures will be analysed over gradation scale.(2 months)
研究者
PROF ANAND K CHAUDHARY
INSTITUTE OF MEDICAL SCIENCES, BANARAS HINDU UNIVERSITY