| CTRI Number |
CTRI/2024/07/069742 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to understand the role of Zingiber officinalis 6C on treating prediabetes. |
|
Scientific Title of Study
|
A Clinical study of Zingiber officinalis 6C on pre-diabetes. |
| 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 KULDEEP K |
| Designation |
Postgraduate student |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
3rd Floor College Building, Department of Practice of medicine, Sarada Krishna Homoeopathic Medical college, Kulasekharam, Kanyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9110289783 |
| Fax |
|
| Email |
krishnamurthybes@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T AJAYAN |
| Designation |
Professor and head of the Department |
| Affiliation |
Sarada Krishna Homoeopathic Medical College. |
| Address |
3rd Floor College Building, Department of Practice of medicine, Sarada Krishna Homoeopathic Medical college, Kulasekharam, Kanyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995605094 |
| Fax |
|
| Email |
tajayandr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T AJAYAN |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
3rd Floor College Building, Department of Practice of medicine, Sarada Krishna Homoeopathic Medical college, Kulasekharam, Kanyakumari District, Tamil Nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9995605094 |
| Fax |
|
| Email |
tajayandr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution-Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District, Tamil Nadu-629161, India |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District, Tamil Nadu-629161, India |
| Type of Sponsor |
Private medical college |
|
|
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 KULDEEP K |
Sarada Krishna Homoeopathic Medical College |
Room No 104, 3B Unit-Practice of Medicine, Outpatient Department And Inpatient Department of Practice of Medicine Kanyakumari, Tamil Nadu
Kanniyakumari
TAMIL NADU |
9110289783
krishnamurthybes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
ZINGIBER OFFICINALIS 6C |
Zingiber Officinalis 6C will be administered to the patients suffering from pre-diabetes. One Dose per week will be given through medicated globules orally. Patient will be asked for regular follow up every two weeks once. The research will be done for the period for 6 Months. Pre and Post fasting blood sugar, Body Mass Index and hba1c levels will be seen. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical symptoms of pre diabetes.
symptoms of zingiber officinalis 6c.
Diagnostic criteria:
As per the guidelines of American diabetes association the criteria. |
|
| ExclusionCriteria |
| Details |
Patients with complications of Diabetes mellitus. Alcoholic dependents. Patients under other
treatments and medications. Pregnant and lactating women are also excluded |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Zingiber officinalis is expected to show reduction in value of fasting blood sugar. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Zingiber officinalis is expected to show reduction in values of HbA1c in pre diabetic patients. |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
02/07/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Prediabetes is a condition defined as having blood glucose levels above normal but below the defined threshold of diabetes. It is considered to be an at risk state, with high chances of developing diabetes. An attempt is taken in this study to understand the effect of Zingiber Officinalis 6c as a treatment remedy for pre diabetes, as relevant studies are not carried out in the higher potency of Zingiber Officinalis. Screening for pre diabetes will be done and cases will be collected from OPD, IPD and rural centers of Sarada Krishna homoeopathic medical college and hospital. With Proper case taking and physical examination around 30 cases of pre diabetes patients having symptoms of zingiber officinalis will be taken for study. Followed by administration of Zingiber officinalis 6c 4 pills once daily, according to the improvement of patient. Post assessment using HbA1c, BMI and FBS will be done.
|