| CTRI Number |
CTRI/2025/01/079767 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
The effectiveness of Calcarea Phosphorica 6X in cases of Vitamin D deficiency or insufficiency in comparison to Individualised Homoeopathic treatment |
|
Scientific Title of Study
|
The comparative effectiveness between Individualised Homoeopathic Medicines and Calcarea Phosphorica 6X in cases of Vitamin D deficiency or insufficiency; An open-label, randomised clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gurjeev Singh AL Gurcharan Singh |
| Designation |
PG student |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Block GE, Sector 3, Bidhannagar, Kolkata, West Bengal, 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
7595904450 |
| Fax |
|
| Email |
gurjeev10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr PRASANTA RATH |
| Designation |
HOD, Department of Community Medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Community Medicine,
Block GE, Sector 3, Bidhannagar, Kolkata, West Bengal, 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr PRASANTA RATH |
| Designation |
HOD, Department of Community Medicine |
| Affiliation |
National Institute of Homoeopathy |
| Address |
Department of Community Medicine,
Block GE, Sector 3, Bidhannagar, Kolkata, West Bengal, 700106
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Block GE, Sector 3, Bidhannagar, Kolkata, West Bengal, 700106. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Dr PRASANTA RATH |
National Institute of Homoeopathy |
Department of Homoeopathic Materia Medica, Room No. 18,
Block GE, Sector 3, Salt Lake, Bidhannagar, Kolkata, West Bengal, 700106
Kolkata
WEST BENGAL |
8420924836
drprasantarath09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of the National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calcarea Phosphorica 6x |
Calcarea Phosphorica will be prescribed in 6X potency, 4 tablets, thrice daily (TDS) for a period of 3 months. |
| Comparator Agent |
Individualised Homoeopathic Medicine |
Individualised Homoeopathic Medicines will be prescribed in potency and dose according to the susceptibility of the patient |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with serum Vitamin D-25(OH) less than 30ng per mL
Patients of all religions and races irrespective of socioeconomic status
Patients willing to take part in the study and for regular follow ups
Patients who are willing to fill the respective consent forms |
|
| ExclusionCriteria |
| Details |
Patients with severe hepatic and renal diseases
Patients with serum Vitamin D-25(OH) less than 5ng per mL
Pregnant and lactating women.
Patients not willing to take part in study and regular follow ups.
Patients having any terminal disease condition.
Patients taking Vitamin D supplements or allopathic medicines for Vitamin D deficiency.
Patients taking Homoeopathic medicines within the last one month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Serum Vitamin D-25(OH) testing using Chemiluminescence Immunoassay (CLIA) technique |
at baseline and after a period of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Calcium testing |
at baseline and after a period of 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
19/02/2025 |
| 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="6"
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
|
Total study duration is for a period of 18 months and each patient will be studied for a period of 3 months. Serum Vitamin D-25(OH) and serum calcium levels of each patient will be measured at baseline and after a period of 3 months. One arm will be given Calcarea Phosphorica 6x and another Individualised Homoeopathic Medicines out of which patients are selected randomly. Since it is an open study the researcher and patient are both aware of medication given. Patients are selected based on the inclusion and exclusion criteria as described. The total sample size is of 60 including a 20% dropout. The effectiveness of Calcarea Phosphorica 6x and Individualised Homoeopathic Medicines will be studied in this study. in case of any adverse events they will be recorded and reported as required. |