Effectiveness of the Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines in the management of Type-2 Diabetes Mellitus: A single-blind randomized controlled clinical trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The changes in HbA1C values.
Study Overview
Brief Summary
This study is a single blind randomized controlled clinical trial to find out the effectiveness of the Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines in the management of Type-2 Diabetes Mellitus . The primary outcome is to assess the changes in glycaemic control in the participants withT2DM after the administration of Individualized Homoeopathic Medicines in LM potencies as an adjuvant to conventional medicines compared tothose who are taking conventional medicines with placebo. The secondary outcomes are to measure the changes in the FBS and PPBS levels and changes in the quality of life using the Quality of Life Instrument for Indian Diabetes Patients (QOLID) Questionnaire at the baseline and at the conclusion of the study.The study duration is 1 year 6 months (inclusive of enrollment period of 1 year and a period of 6 months for the follow-up).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 20.00 Year(s) to 70.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Diagnosed cases of Type-2 Diabetes Mellitus taking conventional anti-diabetic medications.
- •2.Participants with HbA1C levels more than 6.5%.
Exclusion Criteria
- •1.Pregnant women and lactating mothers.
- •2.Cases with known underlying immune deficiencies or serious illness.
Outcomes
Primary Outcomes
The changes in HbA1C values.
Time Frame: Baseline, 6 months (Conclusion of the study).
Secondary Outcomes
- Changes in the FBS and PPBS levels.(Baseline, 6 months(Conclusion of the study).)
- Changes in the quality of life will be assessed using the Quality of Life Instrument for Indian Diabetes Patients (QOLID) Questionnaire(Baseline, 6 months (Conclusion of the study).)
Investigators
Dr Pawan Sharma
National Homoeopathy Research Institute in Mental Health