Effectiveness of the Homoeopathic Medicines Abroma augusta-Q and Gymnema sylvestre-Q in controlling the Blood sugar levels of Diabetes mellitus patients
- Conditions
- Type II Diabetes mellitus
- Registration Number
- CTRI/2017/11/010528
- Lead Sponsor
- Central Council for Research in Homoeopathy
- Brief Summary
Diabetes mellitus is the most common disease of the world causing much Morbidity. It is very evident that the incidence of this disease is rapidly increasing in both developed and developing countries. Also the mean age of acquiring the disease is lowering day by day. The Diabetes mellitus is classified into many types like, Type I / Juvenile, Type II / Non-insulin dependent, Gestational Diabetes, etc., But irrespective of the type affected, the patients suffer equally. India is having the largest Diabetic population of the world. So at this context the Homoeopathic Medicines which can have a Good Diabetic Control should be tested on the patients and to be reported effectively.
By studying the Homoeopathic Literature it is found that the mother tinctures Abroma augusta and Gymnema sylvestre are effective in treating Diabetes mellitus. This intended me to carry out an Experimental Study on Type II Diabetes mellitus patients. The plan of this study is show a statistically significant hypoglycaemic effect using the Homoeopathic medicines on Diabetes mellitus patients. In addition to that the Cholesterol lowering effect is also evaluated. This experiment is executed with a Placebo control group for higher significance.
The Project titled “Placebo controlled comparative study in the modulation of fasting blood glucose and serum cholesterol levels of type-II diabetes mellitus patients with Abroma augusta Q and Gymnema sylvestre Q†(Reference ID : STSH160047) was shortlisted under “Short Term Studentship in Homoeopathy (STSH) 2016 by Central Council for Research in Homoeopathy†on 25.10.2016.
As per the protocol of the study 30 Type II Diabetes mellitus patients were selected randomly from Medical Unit IV of the College Hospital and treated in the period November 2016 to March 2017.
All the patients are explained in detail about the study and treatment procedures in the beginning itself. ‘Informed Consent’ in their local language is also obtained from each patient.
During the study period ‘Monthly Progress Reports and Patient Statistics’ of the Project were submitted to the Principal & Institutional Ethical Committee on 01.12.2016, 04.01.2017 and 04.02.2017.
The project was completed on 04.03.2017 and the same was intimated to the Principal & Institutional Ethical Committee by a ‘Project Completion Report’ on 07.03.2017.
This selection was made on careful consideration of the Inclusion and Exclusion Criteria.
The ‘Case History’ of each patient was recorded in a Standardised case Format.
Then these selected patients were allotted equally in the 3 Treatment Groups by ‘Systematic Random Sampling Procedure’ such that each group carried 10 patients.
Considered Treatment Groups were, Group-A: Abroma augusta Q; Group-B: Gymnema Sylvestre Q & Group-C: Dispensing alcohol as Placebo.
The Pre treatment Fasting Blood Glucose Levels and Serum Total Cholesterol Levels of each patient were tested and recorded.
Few patients were found already under Treatment by other Medications; they were prescribed with placebo for a month and then included in the study.
Each patient was given their respective Treatment for at least 2 months i.e, 60 days.
They were advised to take 10 drops of their respective Mother tinctures / Dispensing alcohol mixed with 10 ml of water orally in morning and night every day after food.
Care was taken in not revealing the name of medicine which is prescribed to that patient. The medicines are coded as A / B / C so as to keep their name secret. Also the placebo was prescribed in the form of “Dispensing Alcohol†so as to make it similar to other medicines.
All the patients were explained about ‘Diabetic Diet’ and advised to follow, which was closely monitored.
The Fasting Blood Glucose Levels of all patients were tested on 3rd, 6th and 9th weeks of their treatment.
The Serum Total Cholesterol Levels of each patient were tested at the end of Treatment.
Some Sample Characters like Age Distribution, Gender Distribution, etc., were analysed.
Analysis of Outcome:
The Pre Treatment and Post Treatment Fasting Blood Glucose & Serum Total Cholesterol Levels were considered for Statistical Analysis using “Analysis of Variance - ANOVAâ€.
Also ‘Correlation Analysis’ was made on Glucose and Cholesterol Modulations together.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- Patient with the diagnosis of type 2 diabetes mellitus.
- Fasting blood glucose more than or equal to 126 mg/dl.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Fasting blood glucose levels in mgs/dL 60 days
- Secondary Outcome Measures
Name Time Method Reduction in Fasting serum total cholesterol levels in mgs/dL 60 days
Trial Locations
- Locations (1)
Vinayaka Missions Homoeopathic Medical College and Hospital
🇮🇳Salem, TAMIL NADU, India
Vinayaka Missions Homoeopathic Medical College and Hospital🇮🇳Salem, TAMIL NADU, IndiaDr A NagarajanPrincipal investigator04272477885principal.vmhmc@vmu.edu.in