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CTRI Number  CTRI/2025/07/090197 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy
Other (Specify) [SUNLIGHT AND VITAMIN D RICH DIET]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A STUDY TO FIND OUT IF HOMEOPATHIC MEDICINES,ALONG WITH SUNLIGHT AND DIET, WORK BETTER THAN JUST SUNLIGHT AND DIET ALONE TO IMPROVE LOW VITAMIN D LEVELS IN PEOPLE AGED BETWEEN 19 TO 50. 
Scientific Title of Study   A SINGLE BLIND RANDOMISED CONTROLLED TRIAL TO ASSESS THE IMPACT OF HOMOEOPATHIC MEDICINES AND AUXILLARY STRATEGIES ON HYPOVITAMINOSIS D IN THE ADULT POPULATION 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SARANYA NAMBIAR S 
Designation  POST GRADUATE SCHOLAR 
Affiliation  GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE 
Address  DEPARTMENT OF PRACTICE OF MEDICINE GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KARAPARAMBA KOZHIKODE KOZHIKODE KERALA 673010 INDIA

Kozhikode
KERALA
673010
India 
Phone  8547131425  
Fax    
Email  saranya.snambiar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR LIZMY JOSE 
Designation  GUIDE 
Affiliation  GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE 
Address  DEPARTMENT OF PRACTICE OF MEDICINE GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KARAPARAMBA KOZHIKODE KOZHIKODE KERALA 673010 INDIA

Kozhikode
KERALA
673010
India 
Phone  9447551747  
Fax    
Email  lizmyajith@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR SARANYA NAMBIAR S 
Designation  POST GRADUATE SCHOLAR 
Affiliation  GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE 
Address  DEPARTMENT OF PRACTICE OF MEDICINE GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KARAPARAMBA KOZHIKODE KOZHIKODE KERALA 673010 INDIA

Kozhikode
KERALA
673010
India 
Phone  8547131425  
Fax    
Email  saranya.snambiar@gmail.com  
 
Source of Monetary or Material Support  
GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE KERALA 
 
Primary Sponsor  
Name  DR SARANYA NAMBIAR S 
Address  POST GRADUATE SCHOLAR DEPARTMENT OF PRACTICE OF MEDICINE GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KOZHIKODE 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR SARANYA NAMBIAR S  GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE   RESEARCH OP DEPARTMENT OP ROOM 9 GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE KARAPARAMBA KOZHIKODE KERALA INDIA
Kozhikode
KERALA 		 08547131425

saranya.snambiar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT HOMOEOPATHIC MEDICAL COLLEGE ,KOZHIKODE ,KERALA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INDIVIDUALISED HOMOEOPATHIC MEDICINE AND AUXILLARY MEASURES.  1) INDIVIDUALISED HOMOEOPATHIC MEDICINES OF SUITABLE POTENCY ACCORDING TO HOMOEOPATHIC PRINCIPLES. 2) AUXILLARY MEASURES SUCH AS SUNLIGHT EXPOSURE TO THE FOREARM AND FACE FOR 20 MINUTES BETWEEN 11AM TO 3PM.DIETARY SOURCES SUCH AS FATTY FISHES,MACKEREL,TUNA,MEAT,BUTTER,MILK,EGG 
Comparator Agent  PLACEBO WITH AUXILLARY MEASURES  1) PLACEBO THAT IS OF THE SAME APPEARANCE AND ADMINISTRATION AS OF THE HOMOEOPATHIC REMEDIES 2) AUXILLARY MEASURES SUCH AS SUNLIGHT EXPOSURE TO THE FOREARM AND FACE FOR 20 MINUTES BETWEEN 11AM TO 3PM. DIETARY SOURCES SUCH AS FATTY FISHES,MACKEREL,TUNA,MEAT,BUTTER,MILK,EGG 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1)CASES WITH INSUFFICIENT 25HYDROXY VITAMIN D RANGING FROM 20-30ng per ml(50-75nmol per liter).
2)CASES WITH DEFICIENT 25HYDROXY VITAMIN D RANGING FROM 20-12ng per ml(30-50nmol per liter). 
 
ExclusionCriteria 
Details  1)PATIENTS WITH CARDIAC,HEPATIC,RENAL COMPLICATIONS.
2)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.
3)PREGNANT WOMEN 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES
DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D
INTERVAL:3MONTHS 		 TITLE:INCREASE IN THE 25HYDROXY VITAMIN D LEVES
DESCRIPTION:FINAL VALUE OF SERUM VITAMIN D-INITIAL VALUE OF SERUM VITAMIN D
INTERVAL:3MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   18/07/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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

 
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