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CTRI Number  CTRI/2017/05/008618 [Registered on: 23/05/2017] Trial Registered Retrospectively
Last Modified On: 18/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of two medicines, Vijaysaradi Ghanvati and Madhumehari Vati in the treatment of Madhumeha (Type 2 Diabetes ) 
Scientific Title of Study   Clinical Study on Vijaysaradi Ghanvati and Madhumehari Vati in the Management of Madhumeha (Type 2 Diabetes ) - An Open Randomized Comparative Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sachin Kumar Sharma 
Designation  MD AYU Scholar Kayachikitsa 
Affiliation  IPGT and RA Gujarat ayurved university 
Address  Department of Kayachikitsa IPGT and RA Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  8005304584  
Fax    
Email  sachin.s.dr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Alankruta R Dave 
Designation  Associate Professor 
Affiliation  IPGT and RA Gujarat ayurved university 
Address  Department of Kayachikitsa IPGT and RA Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  9824171817  
Fax    
Email  alankruta@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Sachin Kumar Sharma 
Designation  MD AYU Scholar Kayachikitsa 
Affiliation  Department of Kayachikitsa IPGT and RA Gujarat Ayurved University Jamnagar Gujarat 361008 
Address  Department of Kayachikitsa IPGT and RA Gujarat Ayurved University Jamnagar

Jamnagar
GUJARAT
361008
India 
Phone  8005304584  
Fax    
Email  sachin.s.dr@gmail.com  
 
Source of Monetary or Material Support  
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India 361008 
 
Primary Sponsor  
Name  Institute for Post Graduate Teaching and Research in Ayurveda 
Address  Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University Jamnagar Gujarat India 361008 
Type of Sponsor  Research institution and hospital 
 
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 Sachin Kumar Sharma  IPGT and RA  Department of Kayachikitsa 4th floor IPGT and RA Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT 		 8005304584

sachin.s.dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Madhumeha (Type 2 Diabetes), (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Madhumehari Vati  Madhumehari Vati will be given in Madhumeha patients in dose of 1 tablet (800mg) tds with plain water before food for 8 weeks.  
Comparator Agent  Vijaysaradi Ghanvati   Vijaysaradi Ghanvati will be given in Madhumeha patients in dose of 2 tablet (300 mg each) tds with plain water before food for 8 weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients having signs and symptoms of Madhumeha (Type 2 Diabetes)
2. Fasting plasma glucose ≥ 126 mg/dl or Post Prandial glucose level ≥ 200 mg/dl.
 
 
ExclusionCriteria 
Details  1. Age less than 20 years more than 70 years.
2. Patients of Diabetes mellitus receiving Insulin.
3. Patients having chronic complications of Diabetes mellitus like Retinopathy, Neuropathy Nephropathy, Coronary artery disease, Peripheral vascular disease, Cerebro-vascular disease and other chronic debilitating disease like STD etc.
4. pregnant and lactating women.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
efficacy  2 month 
 
Secondary Outcome  
Outcome  TimePoints 
safety  2 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   22/02/2017 
Date of Study Completion (India) 19/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
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
Modification(s)  

Total 60 patients of Madhumeha were registered for study, selected patients were divided in two groups on the basis of computer generated randomization.

Group A - Vijaysardi Ghanvati was given 2 Vati (500 mg each) TDS for a duration of 8 weeks with plain water before meal.

Group B - Madhumehari Vati was given 1 tablet (1000mg) TDS for a duration of 8 weeks with plain water before meal.

Effect of therapy:

Prabhutmutrata was reduced by 80% in both groups, which was statistically significant significant.

            Pindikodwestan was reduced by 92% and 81.93% in Group A and B respectively Both the groups had provided statistically significant improvement on Pindikodwestan.

            KaraPada Daha was reduced by 89% and 92.30% in Group A and B respectively. Both the groups had provided statistically significant improvement on KaraPada Daha.

            Kshudadhikya was reduced by 64.3% and 39.75% in Group A and B respectively. Both the groups had provided statistically significant improvement on Kshudadhikya.

            KaraPada Supti was reduced by 90% and 90.44% in Group A and B respectively. Both the groups had provided statistically significant improvement on KaraPada Supti.

            Ati-pipasa was reduced by 64% and 69.38% in Group A and B respectively. Both the groups had provided statistically significant improvement on Ati-pipasa.

            Sweda Adhikya was reduced by 60% and 39.75% in Group A and B respectively. Both the groups had provided statistically significant improvement on Sweda Adhikya.

            Guru Gatrata was reduced by 90% and 100% in Group A and B respectively. Both the groups had provided statistically significant improvement on Guru Gatrata.

            Nindradhikya was reduced by 47.5% and 58.90% in Group A and B respectively.. Both the groups had provided statistically significant improvement on Nindradhikya.

            Group-A and Group-B showed 11.52% and 12.16 reductions in FBS respectively, which was significant in both groups.

            Group-A and Group-B showed 12.66% and 18.55% reduction in PPBS respectively. Reduction in PPBS in Group-A was significant but it was highly significant in Group-B.

            Group-A and Group-B showed 2.56% and 11.47% reduction in HbA1C respectively. Reduction in HbA1C in Group-A was insignificant but it was significant in Group-B.

Group-A and Group-B showed 10.44% and 54.86% decrease in fasting Urine sugar respectively, which was insignificant in Group-A but significant in Group-B.

Overall effect of therapy:

In Group A, complete remission was observed in 3 (11%) patient, markedly improvement was observed in 5 (19%) patients, moderate improvement was observed in 16 (59%) patients, mild improvement was observed in 3 (11%) patients. In Group B, complete remission was observed in 4 (13.5%) patient, markedly improvement was observed in 8 (28%) patients, moderate improvement was observed in 13 (45%) patients, mild improvement was observed in 4 (13.5%) patients.

Ø  On analyzing the data overall Group-B (Madhumehari Vati) showed better results than Group-A (Vijaysaradi Ghanvati Group).


 
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