A Pilot Exploratory clinical study to evaluate the safety and efficacy of Jambusaar- M 100 tablet as an add-on treatment in the patients with type- 2 Diabetes Mellitus

The selected intervention for this study, Jambusaar M 100, Comprises a polyherbal tablet formulation containing several key ingredients with purposeful therapeutic properties for management as an add-on treatment in Type 2 Diabetes Mellitus.

Indication and Use:

As an add-on treatment in Mild to Moderate cases of  Type 2 Diabetes Mellitus.

Study Objectives:

Primary Objective:

To observe changes in DSC-R symptom Score of Type 2 Diabetes Mellitus following Add-on treatment with Jambusaar-M100 tablets over the 12 week study duration.

Secondary Objectives:

To evaluate the Add-on efficacy of Jambusaar-M100 tablet in improving glycaemic control in patients with Type 2 Diabetes Mellitus, as measured by changes in Haemoglobin A1c (HbA1c), Fasting blood Glucose (FBS) & Post prandial Blood Glucose (PPBS) levels over a 12-week period compared with baseline values.

Observe adverse drug reaction of trial Drug Jambusaar-M100.

Study Detail:

Screening Visit (S1):

At the screening visits, (S1) Informed Consent will be taken and documentation of the same will be done. A detail interrogation for medical history, Concomitant Medication or any changes will be documented.  Physical Examinations, Vital Signs (Blood Pressure, Heart Rates, Temperature, BMI), will be measured. Blood collection will be done for the test Fasting blood Glucose (FBS), Post prandial Blood Glucose (PPBS) & HbA1C will be assessed. DSC-R symptom Score questionnaire will be filled. Patients who can provide previous  3 months of symptom data, FBS, PPBS, and at least one HbA1c report. For eligible patients interventional drug, daily diary card and rescue medication will be provided.

Active treatment period:

After the assessment, patients who fulfill all the eligibility criteria will enter in 12 weeks active treatment period. Study Medication, Daily diary Card and Rescue medication will be provided. Training for how to fill the diary will be given. Follow up visits will be scheduled at 4th, 8th  and 12th week after inclusion. Patients will be called accordingly. A window period of ± 3 days will be allowed for each follow up visit.

Visit T4: (4th week)

In this visit, Vital Signs will be checked. Detail physical examination will be done. . DSC-R symptom questionnaire  will be filled. Blood collection will be done for the test FBS & PPBS values will be measured. Daily diary Card will be examined, Medication compliance, use of rescue medication, concomitant medication will be checked. Adverse events if any will be recorded. Study Medication till next follow up will be provided. Patients will be called for next visit after 4 weeks.

Visit T8: (8th week)

In this visit, Vital Signs will be checked. Detail physical examination will be done. DSC-R symptom questionnaire will be filled. Blood collection will be done for the test FBS & PPBS values will be measured. Daily diary Card will be examined, Medication compliance, use of rescue medication, concomitant medication will be checked. Adverse events if any will be recorded. Study Medication till next follow up will be provided. Patients will be called for next visit after 4 weeks.

Visit T12: (12th week)

In this final visit, Vital Signs will be checked. Detail physical examination will be done. DSC-R symptom questionnaire will be filled. Blood collection will be done for the test FBS, PPBS & HbA1C values will be measured. Daily diary Card will be examined, Medication compliance, use of rescue medication, concomitant medication will be checked. Adverse events if any will be recorded.

Study Duration:

The study duration will be total of 12 weeks after being recruited in the study. The whole study will be completed in 9 months period.

Assessment of Study:

Following efficacy and safety parameters will be used for the assessment of the study.

Efficacy Assessment:

Objective assessment measures:

1. FBS

2. PPBS

3. HbA1C

Subjective assessment measures:

DSR Symptom Score questionnaire

Safety assessment:

All the adverse events occurring throughout the treatment course will be recorded and managed accordingly. The safety of the patient will also be assessed by Changes in vital signs & clinically significant laboratory changes (if necessary) at the end of treatment period after administration on of treatment compared with baseline.

Statistical Analysis:

Student’s paired ‘t’ test will be used, whereas non-parametric data will be evaluated using Wilcoxan matched paired test. P<0.05 will be considered as level of significance.