| CTRI Number |
CTRI/2017/11/010528 [Registered on: 16/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
03/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of the Homoeopathic Medicines Abroma augusta-Q and Gymnema sylvestre-Q in controlling the Blood sugar levels of Diabetes mellitus patients |
|
Scientific Title of Study
|
Placebo controlled comparative study in the modulation of fasting blood glucose and serum total cholesterol levels of type-II diabetes mellitus patients with Abroma augusta Q and Gymnema sylvestre Q |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthi S A |
| Designation |
CRRI |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine,
Ground Floor, Clinical Department Block,
Vinayaka Missions Homoeopathic Medical College and Hospital,
NH47, Sankari Main Road,
Seeragapadi,
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9944667414 |
| Fax |
|
| Email |
karthi10817414@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkatesan H |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Ground Floor, Clinical Department Block,
Vinayaka Missions Homoeopathic Medical College and Hospital,
NH47, Sankari Main Road,
Seeragapadi,
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Venkatesan H |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Dept of Practice of Medicine, Ground Floor,
Clinical Department Block,
Vinayaka Missions Homoeopathic Medical College and Hospital,
NH47, Sankari Main Road,
Seeragapadi,
Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missons Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi, Salem, Tamilnadu, Pin code 636 308 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy |
| Address |
61-65, Institutional Area, Opp. D Block, Janak Puri, New Delhi – 110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vinayaka Missons Homoeopathic Medical College and Hospital |
NH47, Sankari Main Road,
Seeragapadi,
Salem,
Tamilnadu - 636308 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr A Nagarajan |
Vinayaka Missions Homoeopathic Medical College and Hospital |
NH47, Sankari Main Road,
Seeragapadi,
Salem
Salem
TAMIL NADU |
04272477885
principal.vmhmc@vmu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type II Diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Abroma augusta-Q
10 drops mixed in 10 ml of water per oral route - Morning and Night after food
60 days for each patient |
| Comparator Agent |
Group B |
Gymnema sylvestre-Q
10 drops mixed in 10 ml of water per oral route - Morning and Night after food
60 days for each patient |
| Comparator Agent |
Group C |
Dispensing alcohol as Placebo
10 drops mixed in 10 ml of water per oral route - Morning and Night after food
60 days for each patient |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient with the diagnosis of type 2 diabetes mellitus.
Fasting blood glucose more than or equal to 126 mg/dl. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Fasting blood glucose levels in mgs/dL |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Fasting serum total cholesterol levels in mgs/dL |
60 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2016 |
| Date of Study Completion (India) |
04/03/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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.
|