A SINGLE BLIND RANDOMISED CONTROLLED TRIAL TO ASSESS THE IMPACT OF HOMOEOPATHIC MEDICINES AND AUXILLARY STRATEGIES ON HYPOVITAMINOSIS D IN THE ADULT POPULATION
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES
研究概览
简要总结
· This is single blind randomised controlled trial to be done with the aim to know the effectiveness of homoeopathic medicines along with auxillary measures or auxillary measures alone in the management of Vitamin D deficiency among outpatient and inpatient sections of Government Homoeopathic Medical College, Kozhikode. Initially screening will be done at Out Patient Department on the basis of inclusion and exclusion criteria. Patient falling under inclusion criteria will be subjected screening specially prepared for it . After that screening of serum 25 – hydroxy vitamin D level of patient will be measured and those who fulfill criteria will be enrolled for the study.The number of samples needed per group is 20. Each Participant will be assigned for either group A (homoeopathic medicine andAuxillary measures) or group B (placebo and Auxillary measures) as intervention through random numbers obtained by block randomization with block size 4 .The patients will be informed that they will be getting either placebo or medicine during the study period. Detailed case taking will be done, after which the totality is constructed. Homoeopathic medicines will be prescribed only to group A and will be administered suitable potency according to Homoeopathic principles. Potency and repetition of medicine can be changed in the follow ups, according to the demand of the case. the cases allocated in group B will be administered with placebo along with auxillary measures.Under auxillary measures, patients will be strictly advised to receive 20 minutes’ sunlight exposure to the forearm and face between 11am to 3pm.over their current exposure duration for 3months.Patients will be also advised to take dietary sources of vitamin D. The final evaluation of the data will be done by means of appropriate parametric tests (25 hydroxy Vitamin D level) After 3 months.The final evaluation of the data will be done by means of appropriate parametric tests (25 hydroxy Vitamin D level) After 3 months.Each case will be reviewed at 4 weeks interval and followed for a period of minimum 3 months. The whole period of study will be 1 year in duration
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
- 19.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •CASES WITH INSUFFICIENT 25HYDROXY VITAMIN D RANGING FROM 20-30ng per ml(50-75nmol per liter).
- •CASES WITH DEFICIENT 25HYDROXY VITAMIN D RANGING FROM 20-12ng per ml(30-50nmol per liter).
排除标准
- •PATIENTS WITH CARDIAC,HEPATIC,RENAL COMPLICATIONS.
- •CASES WITH SEVERELY DEFICIENT 25HYDROXY VITAMIN D RANGING FROM BELOW 12ng per ml(LESS THAN 30nmol per liter)IN PATIENTS AGED BETWEEN 19 TO 50 YEARS.
- •PREGNANT WOMEN.
结局指标
主要结局
TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES
时间窗: TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES | DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D | INTERVAL:3MONTHS
DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D
时间窗: TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES | DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D | INTERVAL:3MONTHS
INTERVAL:3MONTHS
时间窗: TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES | DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D | INTERVAL:3MONTHS
次要结局
未报告次要终点
研究者
DR SARANYA NAMBIAR S
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE
