| CTRI Number |
CTRI/2024/09/073177 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Is homoeopathic drug curcuma longa can reduce the blood sugar level in type 2 Diabetes Mellitus patients? |
|
Scientific Title of Study
|
A comparative study on the effectiveness of curcuma longa with homoeopathic constitutional medicine in lowering hyperglycemia in type 2 Diabetes mellitus -an open label non randomised controlled 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 |
Dr Sahla sherin T |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College Karaparamba Kozhikode |
| Address |
Department of Organon of medicine
Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9645091583 |
| Fax |
|
| Email |
Sherinsahla11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babu k Thomas |
| Designation |
Professor (guide faculty) |
| Affiliation |
Government Homoeopathic Medical College Karaparamba Kozhikode |
| Address |
Department of Organon of medicine
Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9400571035 |
| Fax |
|
| Email |
nbk251@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sahla sherin T |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government Homoeopathic Medical College Karaparamba Kozhikode |
| Address |
Department of Organon of medicine
Government Homoeopathic Medical College Karaparamba Kozhikode
Kozhikode
KERALA
673010
India |
| Phone |
9645091583 |
| Fax |
|
| Email |
Sherinsahla11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College Kozhikode Kerala 673010 India |
|
|
Primary Sponsor
|
| Name |
Dr Sahla sherin T |
| Address |
Post Graduate Scholar
Government Homoeopathic Medical college Karaparamba Kozhikode 673010 |
| 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 |
| Dr Sahla sherin T |
Government Homoeopathic Medical College |
Op no 4
Life style op
Department of organon of medicine
Kozhikode
KERALA |
9645091583
Sherinsahla11@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
curcuma longa |
curcuma longa mother tincture is given in 30 ml of water twice daily. Number of drops of medicine will be adjusted as per the level blood glucose in the patient. |
| Comparator Agent |
homoeopathic constitutional medicines are given |
homoeopathic constitutional medicines are given after taking the case in detail.200th/1M potency of indicated medicine is dispensed in saccharam lactis. To be taken on empty stomach and review after 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients satisfying the case definition
2.Participants of both sexes and all socioeconomic groups |
|
| ExclusionCriteria |
| Details |
1.Patients taking insulin
2.Patients with FBS value above 250mg/dl
3.Diagnosed case of type1 diabetes mellitus or diabetic ketoacidosis
4.Pregnant,lactating women and paediatric age group
5.Cases with serious illness like carcinoma or immunocompromised conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Title: Reduction in the fasting serum glucose concentration
Description: Glucose baseline value-Final glucose concentration
Interval: 2 months |
After medicinal prescription according to homoeopathic principle mean glucose estimation will be repeated after 4 weeks of treatment.obtained values will be taken for analysis. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of therapeutic effectiveness of curcuma longa with homoeopathic constitutional medicine in lowering blood glucose level |
After 1 year(after completion of the study) |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
03/09/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study consist of a comparison between the effectiveness of curcuma longa mother tincture to the homoeopathic constitutional medicines on lowering blood glucose level in type 2 Diabetes mellitus patients.All cases with FBS more than 126mg/dl will be selected after checking the inclusion criteria.A prospective comparative study (open label clinical trial),the cases will be alternatively allocated in two groups.After medicinal prescription according to the methodology of study the same procedure of mean glucose estimation will be repeated after 2-3 weeks of treatment.outcome will be measured by the reduction in serum glucose concentration in all cases. |