Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: Individualized Homoeopathic Medicine: Individualized homoeopathic medicine will be administered as globules size 30 once weekly for 6 months with a 30 min time gap before food or drink.
Sponsors
Jims Homoeopathic Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Serum 25 hydroxy Vitamin D 25 OH D level 20 ng mL confirmed by laboratory testing Presence of clinical symptoms suggestive of Vitamin D deficiency e g fatigue bone or muscle pain weakness low mood Adults aged 18 to 50 years of either sex Willingness to participate in the study and comply with the protocol
Exclusion criteria
Exclusion criteria: Serum 25 hydroxy Vitamin D level 20 ng mL Individuals who do not meet the biochemical criterion for Vitamin D deficiency as per established clinical guidelines will be excluded from the trial Subjects which are having Hb levels 8mg dl 14 Presence of systemic diseases affecting Vitamin D metabolism Individuals diagnosed with chronic illnesses such as Ongoing treatment with medications known to affect Vitamin D levels such as Glucocorticoids Anticonvulsants e g phenytoin carbamazepine Rifampicin Antiretroviral drugs Pregnant and lactating women Women who are currently pregnant or breastfeeding will be excluded due to physiological alterations in Vitamin D metabolism during pregnancy and lactation and for ethical considerations Patients with active bone disorders other than osteo malacia such as Osteoporosis under treatment Paget s disease Primary bone malignancies Metastatic bone disease History of recent fractures or major musculoskeletal injury within the past 6 months which may confound clinical assessment of bone and muscle symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess and compare the change in serum 25hydroxyvitamin D 25 OH D levels after administration of individualized homoeopathic medicine versus placebo over the study period of 6 months Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the clinical efficacy of individualised Homoeopathic medicine compared to placebo in improving symptoms associated with vitamin D deficiency in adults. Timepoint: 6 months;Clinical Symptom Score Improvement Change in the severity of key symptoms associated with Vitamin D deficiency such as fatigue bone & muscle pain general weakness mood disturbances measured using a VAS scale Assessment will be done at baseline 6 weeks and 12 weeks Improvement in General Well Being Assessed through a general health visual analogue scale VAS Fatigue Assessment Measured using a validated Fatigue Severity Scale FSS at baseline and follow-up visitsTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactBandarupalli Harsha vardhan
KNRUHS
Outcome results
None listed