A SINGLE BLIND RANDOMISED CONTROLLED TRIAL TO ASSESS THE IMPACT OF HOMOEOPATHIC MEDICINES AND AUXILLARY STRATEGIES ON HYPOVITAMINOSIS D IN THE ADULT POPULATION
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- DR SARANYA NAMBIAR S
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES
Overview
Brief Summary
· 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 19.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES
Time Frame: 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
Time Frame: 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
Time Frame: TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES | DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D | INTERVAL:3MONTHS
Secondary Outcomes
No secondary outcomes reported
Investigators
DR SARANYA NAMBIAR S
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE