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Clinical Trials/CTRI/2024/09/073177
CTRI/2024/09/073177Not yet recruitingPhase 3

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

Dr Sahla sherin T1 site in 1 country42 target enrollmentStarted: September 3, 2024Last updated:

Trial Snapshot

Phase
Phase 3
Status
Not yet recruiting
Sponsor
Enrollment
42
Locations
1
Primary Endpoint
Title: Reduction in the fasting serum glucose concentration

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
30.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patients satisfying the case definition 2.Participants of both sexes and all socioeconomic groups.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Title: Reduction in the fasting serum glucose concentration

Time Frame: 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.

Description: Glucose baseline value-Final glucose concentration

Time Frame: 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.

Interval: 2 months

Time Frame: 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 Outcomes

  • Comparison of therapeutic effectiveness of curcuma longa with homoeopathic constitutional medicine in lowering blood glucose level(After 1 year(after completion of the study))

Investigators

Sponsor
Dr Sahla sherin T
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Sahla sherin T

Government Homoeopathic Medical College Karaparamba Kozhikode

Study Sites (1)

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