| CTRI Number |
CTRI/2025/04/085149 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
19/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
The study mainly focuses on assessing the causative factors which leads to vitamin-D deficiency particularly in the Age Group of 20 to 35 years in both males and females |
|
Scientific Title of Study
|
An Observational Study To Assess The Status Of Dosha, Dushya and Agni In Vitamin-D Deficient Individuals Of Age Group 20-35 years |
| 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 Anju Saranya L K |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda Medical college Pariyaram Kannur |
| Address |
Department of Roganidana Government Ayurveda Medical college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
08943805467 |
| Fax |
|
| Email |
dranjusanin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P M MADHU |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurveda Medical college Pariyaram Kannur |
| Address |
Department of Roganidana
Government Ayurveda Medical college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9447706756 |
| Fax |
|
| Email |
drpmmadhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PM MADHU |
| Designation |
Assistant professor |
| Affiliation |
Government Ayurveda Medical college Pariyaram |
| Address |
Department of Roganidana Government Ayurveda Medical college Pariyaram Kannur
Kannur
KERALA
670503
India |
| Phone |
9447706756 |
| Fax |
|
| Email |
Drpmmadhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical college Pariyaram Kannur 670503 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical Pariyaram Kannur |
| Address |
Government Ayurveda Medical Pariyaram Kannur 670503 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Anju Saranya L K |
Government Ayurveda Medical college Pariyaram Kannur |
Department of Roga nidana 670503
Kannur
KERALA |
08943805467
dranjusanin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Kannur Pariyaram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E559||Vitamin D deficiency, unspecified. Ayurveda Condition: SROTOVAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with Vitamin-D less than 20ng/ml |
|
| ExclusionCriteria |
| Details |
Individuals with serious systemic illness,psychatric illness,Anti epileptic and Anti tubercular drug,who underwent hysterectomy, pregnant women ,lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| By this study we can assess the causative factors involving in the vitamin-D deficiency |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing Causative factors helps in the treatment aspect |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="0"
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
|
The study mainly focuses on assessing the causative factors which affect the vitamin-D metabolism leading to its deficiency |