| CTRI Number |
CTRI/2025/07/090435 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can Homeopathic Medicines Help Reduce Blood Sugar and Uric Acid in People Who Have Both Type 2 Diabetes and High Uric Acid? A Study |
|
Scientific Title of Study
|
The effectiveness of homoeopathic medicines in lowering blood glucose and uric acid levels in patient with co-existing type II diabetes mellitus and hyperuricemia - A quasi experimental study |
| 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 Nijisha K |
| Designation |
Post Graduate Scholar |
| Affiliation |
Government homoeopathic medical college |
| Address |
Government homoeopathic medical college
Karaparamba
Kozhikode
673010
Government homoeopathic medical college
Karaparamba
Kozhikode
673010
Kozhikode
KERALA
673010
India |
| Phone |
7356448827 |
| Fax |
|
| Email |
nijiksajeevan28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Hameed |
| Designation |
Professor |
| Affiliation |
Government homoeopathic medical college |
| Address |
OP- 3
Department of practice of medicine
Government homoeopathic medical college
Karaparamba
Kozhikode
673010
OP-3
Department of practice of medicine
Government homoeopathic medical college
Karaparamba
Kozhikode
673010
Kozhikode
KERALA
673010
India |
| Phone |
9447632227 |
| Fax |
|
| Email |
hameeddr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nijisha K |
| Designation |
PG student |
| Affiliation |
Government homoeopathic medical college |
| Address |
OP room number - 3
Department of practice of medicine
Government homoeopathic medical college
Karaparamba
Kozhikode
673010
OP room number-3
Department of practice of medicine
Government homoeopathic medical college karaparamba
kozhikode
673010
Kozhikode
KERALA
673010
India |
| Phone |
7356448827 |
| Fax |
|
| Email |
nijiksajeevan28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nijisha K |
| Address |
PG student
Government homoeopathic medical college
Karaparamba P.O Kozhikode
kerala , India
pin - 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 Nijisha K |
Government homoeopathic medical college |
department of practice of medicine
Hospital Op
practice of medicine OP - room 3
Kozhikode
KERALA |
7356448827
nijiksajeevan28@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: E790||Hyperuricemia without signs of inflammatory arthritis and tophaceous disease, (2) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
homoeopathic medicine |
Homoeopathic medicines for diabetes and hyperurecemia selected based on Homoeopathic principles of similarity and minimum dose then administered orally for 6 months and the outcome was assessed by fasting blood glucose level and serum uric acid level. The total study duration is for 1 year |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients within 30 to 80 years old.
Patient having both diabetes and hyperuricemia.
Patient with FBS greater than 150mg per dl. |
|
| ExclusionCriteria |
| Details |
Patients with type 1 diabetes mellitus or other types of diabetes.
2. Patients with secondary causes of hyperuricemia (cancer, or use of certain
medications). .
3. Patients with severe comorbidities or complications that may interfere with the study
outcomes (e.g., end-stage renal disease, liver failure, or severe cardiovascular
disease).
4. Patients receiving systemic corticosteroid therapy or other immunosuppressive
medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. changes in fasting blood glucose level
2. changes in serum uric acid level |
1. changes in fasting blood glucose level will be checked after 6 months of giving medicines
2. changes in serum uric acid level will be checked after 6 months of giving medicines
total duration of study is 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/07/2025 |
| 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
|
A prospective clinical study will be conducted in patients attending the outpatient sections of the Government Homoeopathic Medical College, Kozhikode. The period of study will be minimum of 1 year from date of onset of research. A minimum of 24 cases of patients coexisting with hyperuricemia and diabetes satisfying the inclusion and exclusion criteria will be taken up for the study. Consent is obtained after explaining the study in detail to the individual. Blood glucose level and serum uric acid will be done. All cases will be treated according to the principles of Homoeopathy. Each case will be reviewed at6 months . Outcome of the treatment will be assessed by changes in blood glucose level and serum uric acid level. Final evaluation of data will be done by means of an appropriate statistical method. |