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CTRI Number  CTRI/2017/09/009765 [Registered on: 14/09/2017] Trial Registered Retrospectively
Last Modified On: 29/05/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study on AYUBES CAPSULE in Diabetes 
Scientific Title of Study   A Randomized, Multi-center, Double blind, Placebo controlled, Prospective Clinical Study to Evaluate the efficacy and safety of AYUBES CAPSULE as an add-on therapy to Oral Hypoglycemic Agents (OHA) in Type 2 Diabetic Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AYUBES/DM/WELX/2017, Version 1.0, 25th Mar 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pavan Kumar Godatwar 
Designation  Associate Professor and HOD 
Affiliation  National Institute of Ayurveda Jaipur 
Address  Roganidana and Vikriti Vijnana National Institute of Ayurveda Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9314502834  
Fax  09322522252  
Email  gpawankumar@rediffmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax  09322522252  
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vandana Bade 
Designation  Manager - Clinical Trial Operation 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  8149507065  
Fax    
Email  vandana@targetinstitute.in  
 
Source of Monetary or Material Support  
Welex Laboratories Pvt. Ltd. 1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13 
 
Primary Sponsor  
Name  Welex Laboratories Pvt Ltd 
Address  1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran Mutnali  KLEU Shree BMK Ayurved Mahavidyalaya KLUE Ayurved Hospital and Research Center Belgavi  Department of Kayachikitsa OPD Building Ground Floor Belgavi Karnataka 590003
Belgaum
KARNATAKA 		 9164648888

drkiranmutnali@gmail.com 
Dr Narendrakumar B Mundhe  KVTR Ayurvedic College Boradi  OPD No 5 Ground Floor Department of Kayachikitsa KVTR Ayurvedic College Boradi Tal Shirpur Dist Dhule 425428
Dhule
MAHARASHTRA 		 9850378206

drnbmundhe@gmail.com 
Dr Pavan Kumar Godatwar  National Institute of Ayurveda Jaipur  Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002
Jaipur
RAJASTHAN 		 9314502834

gpawankumar@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects KLE University’s Shri B.M. kankanawadi Ayurved Mahavidyalaya & KLE Ayurved Hospital,Shahapur,Belgavi  Approved 
Institutional Ethics Committee National Institute of Ayurveda Jaipur  Approved 
KVTR Ayurvedic College, Boradi, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  AYUBES Capsules  contains Gymnema sylvestre, Momordica charantia, Pterocarpus marsupium, Andrographis paniculata, Aegle marmelos, Syzgiumm cumini, Enicostemma littorale, Picrorhiza kurroa, Azadiracta indica, Cyperus rotundus. Dosage and Treatment Duration: 2 Capsules twice daily orally after meals with lukewarm water for 3 months. 
Comparator Agent  Placebo  Dosage and Treatment Duration: 2 Capsules twice daily orally after meals with lukewarm water for 3 months. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects suffering from type 2 diabetes mellitus for more than one year, and taking mono / poly drug oral hypoglycemic agent(s) for at least last 3 months.
2.Subjects having HbA1C value 6-10% (both inclusive) at screening.
3.Subjects having Fasting Plasma Glucose between 126 -250 mg/dl (both inclusive) at screening.
4.Subjects having postprandial glucose not more than 350 mg/dl at screening.
5.Subject’s ECG not demonstrating any signs of uncontrolled arrhythmia / acute Ischemia and X- ray chest not showing any active lesion of tuberculosis.
6.A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is greater than 2 years post menopause.
 
 
ExclusionCriteria 
Details  1.Patients on insulin therapy.
2.Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2
3.Patients with known history of chronic hepatic or renal disease.
4.Patients with known history of active malignancy.
5.Patients with known history of significant cardiovascular event & lt; 12 weeks prior to randomization.
6.Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
7.Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8.Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
9.History of Use of any other investigational drug within 1 month prior to randomization.
10.Known history of hypersensitivity to ingredients used in study drug.
11.Pregnant and Lactating females.
12.Any other conditions which in the opinion of investigator will place the Patients at risk or will influence the conduct of study or interpretation of results
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Assessment of change in dose of OHA(s) over a period of three months.
2.Assessment of change in Quality of life of patient over three months of treatment.
 		 Day 0, Day 30, Day 60, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of changes in fasting & postprandial plasma glucose levels.
2.Assessment of changes in post treatment HbA1C %
3.Assessment of changes in post treatment Serum Insulin level.
4.Assessment of changes in clinical symptoms of Type 2 DM
5.Assessment of level of energy, stamina and physical strength
6.Assessment of level of stress.
7.Global assessment for overall improvement
8.Assessment of tolerability of study drugs.
9.Assessment of Laboratory parameters.
 		 Day 0, Day 30, Day 60, Day 90 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "78"
Final Enrollment numbers achieved (India)="78" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   26/06/2017 
Date of Study Completion (India) 21/08/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet Done 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Brief Methodology:

It is a Randomized, Multi-center, Double blind, Placebo controlled, Prospective Clinical study to Evaluate the Efficacy and Safety of AYUBES CAPSULE as an Add-on therapy to Oral Hypoglycemic Agents (OHA) in Type 2 Diabetic Patients. The study will be conducted at two sites in India. As per computer generated randomization list, subjects will either receive Ayubes or Placebo in a dose of 2 capsules twice daily with Luke warm water after meals for 3 months. The primary objectives of the study will be to evaluate change in dose of OHA(s) over a period of three months, and change in Quality of life of patient over three months of treatment. The secondary objectives of the study will be to evaluate changes in fasting & postprandial plasma glucose levels, changes in post treatment HbA1C %, changes in post treatment Serum Insulin level, changes in clinical symptoms of Type 2 DM, level of energy, stamina and physical strength, level of stress, global assessment for overall improvement by patient and investigator, tolerability of study drugs and laboratory parameters on day 0, day 30, day 60, day 90.

Results:

A total of 78 subjects were considered as completers. Out of these 78 subjects, 67 subjects were considered as efficacy evaluable cases as 11 subjects were found to be non-compliant or non adherent to the protocol requirements. There were 35 evaluable cases in Ayubes group and 32 evaluable cases in the Placebo group.

The mean age of subjects in Ayubes group was 54.74 ±11.52 years and placebo group was 58.16 ±10.88 years. It was observed that in Ayubes Group there were 4 subjects of Kapha-Pittaja Prakruti, 1 subject of Kapha Vataj Prakruti, 11 subjects of Pitta-Kaphaja Prakruti, 10 subjects of Pitta Vataja Prakruti, 2 subjects of Vata- Kaphaja prakruti and 4 subjects of Vata- Pittaja Prakruti. In Placebo Group, there was 1 subject of Vataj prakruti, 3 subjects of Kapha-Pittaja Prakruti, 7 subjects of Pitta-Kaphaja Prakruti, 11 subjects of Pitta Vataja Prakruti, 1 subjects of Vata- Kaphaja prakruti and 5 subjects of Vata- Pittaja Prakruti.

It was observed that in Ayubes Group there were 17 subjects of BMI between 18.5 to 24.9 kg/m2, 9 subjects of BMI between 25 to 29.9 kg/m2 and 6 subjects of BMI more than 30 kg/m2. In Placebo Group there was 1 subject less than 18.5 kg/m2, 9 subjects of BMI between 18.5 to 24.9 kg/m2, 17 subjects of BMI between 25 to 29.9 kg/m2 and 3 subjects of BMI more than 30 kg/m2.

It has been observed that few subjects in placebo group required increase dosages of OHAs and there were no single subject in Ayubes group who required increase dosages of OHAs, at the end of the study. Also, the number of subjects who required decrease in dose of OHA was more in Ayubes group as compared to placebo group. However, the difference between the groups in above parameters was statistically insignificant (p > 0.05).

As per quality of life assessment using WHO-QOL questionnaire, no significant (p > 0.05) change was observed in physical health, psychological health, social health and environmental health domains at the end of the study in both study groups.

In Ayubes Group, the mean fasting sugar level was 159.51 ±30.98 at baseline visit, which reduced 139.65 ±53.57 and 126.33 ±39.97 on day 30 and day 90 respectively. These changes were found to be statistically significant. At the end of 60 days, the mean fasting blood sugar level was 145.22 ±49.75 (non-significant change). In the Placebo Group, mean fasting blood sugar at the baseline was 160.74 ±28.07 which reduced to 147.14 ±36.99, 155.08 ±43.28 and 148.03 ±43.77 on day 30, 60 and 90 respectively. These changes were found to be non-significant as compared to the baseline at all follow up visits in this group. On analyzing between the two groups it was observed that there was no significant difference at baseline and further at all follow up visits.

In Ayubes Group, the mean post prandial sugar level was 241.71 ± 53.90 at baseline visit, which reduced significantly to 212.83 ±66.44, 215.34 ±56.44 and 216.54 ±62.05 on day 30, 60 and 90 respectively. In Placebo Group, the mean post prandial blood sugar level at baseline was 240.31 ±53.80, which reduced significantly to 212.33 ±71.50 on day 30. The mean postprandial blood sugar level slightly increased non-significantly from baseline visit to 241.58 ±71.53 on day 60. The mean postprandial blood sugar level significantly reduced from baseline visit to 202.48 ±51.22 on day 90. On analyzing between the two groups it was observed that there was no significant difference at baseline and further at all follow up visits.

In Ayubes Group, the mean HbA1C % level at baseline visit was 7.72 ±1.09 which reduced to 7.26 ±1.06 on day 90. In the Placebo Group, the mean HbA1C % level at the baseline was 7.51 ±1.10 which reduced to 7.19 ±1.06 on day 90. These changes were found to be significant as compared to the baseline in both the groups. On analysing between the two groups, no significant difference was observed.

In Ayubes Group, the mean serum Insulin level at baseline visit was 7.97 ±7.60, which reduced to 7.25 ±3.77 on day 90. In the Placebo Group, the mean serum Insulin level at the baseline was 7.52 ±6.35 which reduced to 7.15 ±5.75 on day 90. These changes were found to be non-significant as compared to the baseline visit in both the groups. On analyzing between the two groups, no significant difference was observed.

Statistically significant (p < 0.05) reduction in clinical symptoms of diabetes mellitus such as polyuria and fatigue was observed in subjects of both the study groups. When compared between the groups, polyuria was decreased significantly (p < 0.05) in Ayubes group than placebo group.

Ninety days treatment with Ayubes capsule showed no significant (p > 0.05) improvement in WHO-QOL scores in subjects with type 2 DM; significant (p < 0.05) improvement in energy, stamina and physical strength levels was observed in Ayubes group than that of placebo group at the end of the study.

In Ayubes Group the mean baseline score of level of stress was 46.14 ±19.25 which reduced non-significantly to 44.52 ±14.57 on day 30 and. The mean stress score reduced significantly from baseline to 38.33 ±16.63 and 37.50 ±17.96 on day 60 and 90 respectively. In the Placebo Group, the level of Stress at the baseline was 41.29 ±21.25 which reduced to 39.67 ±20.25 and 36.54 ±19.99 on day 30 and day 60 respectively (non-significant). The mean stress level reduced significantly from baseline visit to 35.17 ±20.46 on day 90. On analysis between the two groups no significant difference was observed.

As per global assessment for overall changes by physician and patient, the majority of patients were showed minimal to much improvement in Ayubes capsule group at the end of the study.

Total 25 subjects (13 subjects in Ayubes group and 12 subjects in placebo group) were reported to have AEs during the study. The majority of AEs were not found to be related to study drugs. Also, no treatment or interruptions of the study drugs or procedures were required to resolve AE episodes. Almost all patients showed excellent tolerability to the study drugs at the end of the study. At the end of the study, no clinically significant (p > 0.05) changes were found in the vitals and laboratory parameters in subjects of both study groups.

Conclusion:

From the results of the present study, it can be concluded that 90 days of treatment with Ayubes capsule as add on therapy to OHAs was effective in reducing the requirements of OHAs. At the end of the study, significant improvement in fasting blood sugar level, HbA1C% level, clinical symptoms of diabetes mellitus (polyuria and fatigue), stress, energy stamina and physical strength were observed in Ayubes Group. At the end of the study, no clinically significant (p > 0.05) changes were found in the vitals and laboratory parameters in Ayubes Group. Thus Ayubes capsule is safe and effective as an add-on therapy to oral hypoglycemic agents (OHA) in patients suffering from type II diabetes mellitus.


 
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