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CTRI Number  CTRI/2018/09/015869 [Registered on: 28/09/2018] Trial Registered Prospectively
Last Modified On: 16/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study of mustadi kwatha and vangeshwara rasa in the management of madhumeha (Type 2 Diabetes mellitus) 
Scientific Title of Study   A randomized comparative clinical study to evaluate the efficacy of mustadi kwatha and vangeshwara rasa in the management of madhumeha w.s.r. to type 2 Diabetes mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hari Khanal 
Designation  MD Scholar  
Affiliation  National Institute of Ayurveda  
Address  PG Department of Kayachikitsa National Institute of Ayurveda,Madhav Vilas Palace,Jorawar Singh Gate Jaipur,Rajasthan.

Jaipur
RAJASTHAN
302002
India 
Phone  8875712514  
Fax    
Email  khanalhari061@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Ram Kishor Joshi 
Designation  Professor  
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda,Madhav Vilas Palace,Jorawar Singh Gate Jaipur,Rajasthan.

Jaipur
RAJASTHAN
302002
India 
Phone  9414322297  
Fax    
Email  joshirk1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Hari Khanal 
Designation  MD Scholar 
Affiliation  National Institute of Ayurveda 
Address  PG Department of Kayachikitsa National Institute of Ayurveda,Madhav Vilas Palace,Jorawar Singh Gate Jaipur,Rajasthan.

Jaipur
RAJASTHAN
302002
India 
Phone  8875712514  
Fax    
Email  khanalhari061@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav Vilas Palace Jorawor Sing Gate, Jaipur Rajasthan. 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav Vilas Palace,Jorawar Sing Gate,Jaipur,Rajasthan 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
Dr Hari Khanal  PG Department of Kayachikitsa, National Institute of Ayurveda,Madhav Vilas Palace, Jorawar Singh Gate,Jaipur,Rajasthan 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Khanal  National Institute of Ayurveda   Kayachikitsa Department OPD/Room No.-1,7,18 and 25.Madhav Vilas Palace,Jorawar Singh Gate,Jaipur,Rajasthan
Jaipur
RAJASTHAN 
8875712514

khanalhari061@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, National Institute of Ayurveda  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, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  In this group 15 patients will be administered trial drug mustadi kwatha orally in the dose of 50 ml twice a day before meals for 45 days.  
Intervention  Group B  In this group 15 patients will be administered vangeshwara rasa 250 mg orally twice a day before meals for 45 days with lukewarm water. 
Intervention  Group C  – In this group 15 patients will be administered 50 ml mustadi kwatha (before meals) along with 250 mg vangeshwara rasa (before meals) orally twice a day for 45 days. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient willing to sign the consent form.
2. Patients in the age group of 30-70 years.
3. Patients with Fasting Blood Sugar (FBS) in the range of 126mg/dl – 250mg/dl or Post Prandial Blood Sugar (PPBS) in the range of 200mg/dl – 300 mg/dl and Glycosylated Haemoglobin (HbA1c) 6.5% - 9.0% .
 
 
ExclusionCriteria 
Details  1. Patients below 30 years & above 70 years of age.
2. Patients having Type 1 DM.
3. Patients of Type 2 DM who are on insulin therapy.
4. Patients having any serious illness like coronary artery disease, malignancy, kidney failure etc.
5. Patient whose Fasting Blood Sugar (FBS) > 250 mg/dl or Post Prandial Blood Sugar (PPBS) > 300 mg/dl or Glycosylated Haemoglobin (HbA1c) > 9.0%.
6. DM with complications.
7. Pregnant women and lactating mother. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in Blood Sugar Level (FBS,PPBS) and specific signs and symptoms of Madhumeha (Type 2 Diabetes Mellitus)  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Any adverse effect in the values of hematological test and in clinical signs and symptoms.  45 days 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  
30/11/2019 
Date of Study Completion (India) 22/03/2020 
Date of First Enrollment (Global)  30/11/2019 
Date of Study Completion (Global) 22/03/2020 
Estimated Duration of Trial   Years="1"
Months="6"
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)  

Diabetes Mellitus (DM) is a clinical syndrome characterised by hyperglycaemia due to absolute or relative deficiency of insulin. Diabetes Mellitus is classified into two broad categories: Type 1 DM and Type 2 DM. Type 1 DM is a result of absolute deficiency of insulin while Type 2 DM is a heterogeneous group of disorders characterised by variable degrees of insulin resistance, impaired insulin secretion and increased glucose production.

Diabetes Mellitus usually presents with symptoms like polyuria, polydipsia and polyphagia. Over time, DM can damage the heart, blood vessels, eyes, kidneys and nerves. According to aetiological factors, pathogenesis and clinical features, Diabetes mellitus can be correlated with Madhumeha in Ayurveda. Madhumeha is the result of untreated Prameha. It is Vataja Prameha where the Vata depletes all Dhatu except Asthi Dhatu and Oja by excreting them through urine leading to Prabhuto Avila Mutrata.Although new drugs and therapeutics are emerging for the management of Diabetes Mellitus (DM), its prevalence is increasing at an alarming rate. DM does not come alone it brings with itself various acute and chronic metabolic complications of hyperglycaemia affecting every organ from head to toe. Once an individual is diagnosed with DM the dosage of medicine is ever increasing and ultimately insulin has to be given for glycemic control in most of the cases. 

Ayurveda has a great potential in the management of Madhumeha (Type 2 DM) and its associated complications.This study finds that Type 2 diabetes mellitus is more prevalent in the elderly population. More specifically, the prevalence of disease is more in 4th, 5th, and 6th decade of life. This finding is consistent with many other studies across different parts of the world. Similarly, the prevalence of disease is more in patients with sedentary life, lack of exercise and faulty food habits in comparison with the patients performing regular physical activity and having regular healthy diet.

 Thus, the results of this study imply that food and exercise play a major role in controlling the blood glucose level. Another interesting findings of this study is that only a few of the 45 registered patient have a classical symptoms of the disease whereas most of the patient are symptomless, but those patients were having a high blood sugar level. This suggests the need of regular medical check-up the elderly people because these people might have been affected by the disease even if they do not show any related symptoms. 

In the present study both Mustadi Kwatha and Vangeshwara Rasa reduce many symptoms of  Madhumeha (Diabetes Mellitus) that include Prabhoota Mutrata  (Polyuria), Avila Mutrata (Turbidity), Trishnadhikya (Excessive Swaeting), Kara Pada Supti (Numbness of Extremities) and Daurbalya (Weakness) significantly. While in Kara Pada Daha (Burning sensation in hands and Feet) and in Kshudadhikya  (Polyphagia) minimum improvement was observed.

The sample size of this study may not be adequate to determine the effectiveness of the drugs in some variables like Avila Mutrata, Karapada Daha and Kshudhadhikya which are present in fewer patient. Regarding overall improvement in objective parameters, Vangeshwara Rasa alone and in combination with Mustadi Kwatha provide highly significant p<0.001 reduction in FBS and PPBS, While Mustadi Kwatha provide significant p<0.05 reduction in FBS and PPBS. The trial drug Mustadi Kwatha is more effective in reducing serum cholesterol and triglyceride in comparison to Vangeshwara Rasa. Similarly, Vangeshwara Rasa have shown significant increment in HDL as compare to Mustadi Kwatha. 

These results suggest the positive effect of the trial drugs in this study. The results were non-significant in parameters like SGOT, SGPT, Blood Urea, Serum Creatinine, Urine protein. They were within normal range after 45 days of administration of these drugs. The findings imply that there were no any adverse effect of these drugs. Diabetes is often associated with obesity, dyslipidaemia, hypertension, insulin resistance, known as metabolic syndrome.

From the present study we can say that both the drug Mustadi Kwatha and Vangeshwara in combined form are capable to handle Diabetes as well as its associated condition.

 
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