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CTRI Number  CTRI/2024/11/076770 [Registered on: 13/11/2024] Trial Registered Prospectively
Last Modified On: 12/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Study on the Safety and Benefits of Jambusaar-M 100 tablet as an additional treatment for Type 2 Diabetes 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shital Rasane  
Designation  Professor  
Affiliation  Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri, Pune, Maharashtra, India-411018 
Address  Dr. D.Y. Patil College Road Sant Tukaram Nagar Pimpri Colony Pimpri- Chinchwad Pune Maharashtra India- 411018

Pune
MAHARASHTRA
411018
India 
Phone  9503330831  
Fax  -  
Email  shital.rasane@dpu.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shital Rasane  
Designation  Professor  
Affiliation  Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri, Pune, Maharashtra, India-411018 
Address  Dr. D.Y. Patil College Road Sant Tukaram Nagar Pimpri Colony Pimpri- Chinchwad Pune Maharashtra India- 411018

Pune
MAHARASHTRA
411018
India 
Phone  9503330831  
Fax  -  
Email  shital.rasane@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Radhikaba P Zala 
Designation  PG Scholar 
Affiliation  Dr. D. Y. Patil College of Ayurved & Research Centre, Pimpri, Pune, Maharashtra, India-411018 
Address  Dr. D. Y. Patil College of Ayurved and Research Centre, Dr. D.Y. Patil College Road Sant Tukaram Nagar Pimpri Colony Pimpri- Chinchwad Pune, Maharashtra, India- 411018

Pune
MAHARASHTRA
411018
India 
Phone  9880587927  
Fax  -  
Email  zalaradhika034@gmail.com  
 
Source of Monetary or Material Support  
Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune, Maharashtra- 411018 
 
Primary Sponsor  
Name  Sudhatatva Pharmacy 
Address  Dr. D. Y. Patil College road, Sant- Tukaram nagar, Pimpri colony, Pimpri- Chinchwad, Pune, Maharashtra- 411018 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shital R Rasane  Dr. D.Y. Patil College of Ayurved College and Research Centre, Pimpri  Kayachikitsa OPD (no. 05) and Male IPD. Female IPD, Panchakarma OPD (no. 09) and male IPD, female IPD, Dr. D.Y. Patil College of Ayurved and Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra-411018
Pune
MAHARASHTRA 		 9503330831
-
shital.rasane@dpu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. DYPCA and RC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Jambusaar M 100, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  64.00 Year(s)
Gender  Both 
Details  Clinically diagnosed Type 2 DM disorder participants Fasting Blood Sugar Range between 100 to 150 mg per dL Post Prandial Blood Sugar Range between 140 to 300 mg per dL HbA1c Range between 5.7 to 10 Patients Body Mass Index BMI between 18.5 and 35 kg per mt square Patients on allopathic medication for Type 2 DM who can provide 3 months of symptom data, along with FBS, PPBS, and at least one HbA1c report 
 
ExclusionCriteria 
Details  Patient who is known case of Type-1 Diabetes mellitus.
Individuals with known allergies to the Disease specific.
Pregnant or breastfeeding women.
Individuals with associated comorbidities.
Recent participation in another clinical trial.
Use of medications known to interact with the study drug.
Patients with acute complications like Hyperglycemic coma, Ketoacidosis and Gangrene.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
changes in DSC-R symptom Score of Type 2 Diabetes Mellitus  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in fasting blood glucose levels.
Impact on postprandial blood glucose levels.
Reduction in Glycated Haemoglobin (HbA1c) levels
 		 12 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   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. 
 
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