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CTRI Number  CTRI/2021/01/030636 [Registered on: 20/01/2021] Trial Registered Prospectively
Last Modified On: 12/01/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   Hypoglycemic Effect Using Ayurveda Treatment For The Management Of Madhumeha(Diabetes Mellitus Type 2) 
Scientific Title of Study   Assessment Of Hypoglycemic Effect Using Holistic Approach Of Ayurveda Protocol For The Management Of Prameha/Madhumeha With Special Reference To DM Type 2 Using Different Dosages Pattern: A Therapeutic Clinical Trial 
Trial Acronym  AHHAPMPMDM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kundan Wasnik 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda 
Address  Room no 618 6th floor academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
OPD No 7 ground floor Hospital block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South West
DELHI
110076
India 
Phone  9175073644  
Fax    
Email  kundanwasnik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raja Ram Mahto 
Designation  Assistant Professor 
Affiliation  All India Institute of Ayurveda 
Address  Room no 618 6th floor academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
6th floor academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South West
DELHI
110076
India 
Phone  8877033663  
Fax    
Email  mahtorajaram@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rama Kant Yadava 
Designation  Associate Professor  
Affiliation  All India Institute of Ayurveda 
Address  Room no 618 6th floor academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
6th floor academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi
South West
DELHI
110076
India 
Phone  9412148437  
Fax    
Email  drrky68@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda  
Address  All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076 
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 Kundan Wasnik  All India Institute of Ayurveda  OPD no 07 Ground floor Hospital Block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi 110076
South West
DELHI 
9175073644

kundanwasnik@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  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: Diabetes Mellitus Type 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nishakathakadi Kwatha Mamajjaka Ghana Vati Gokshuradi guggulu  Mild cases Nishakatakadi Kwatha 40 ml BD Gokshuradi Guggulu 500 mg BD Mamajjaka Ghana Vati 500 mg Tab BD Each medicine Before Meal for 90 days Moderate cases Nishakatakadi Kwatha 40 ml TID Gokshuradi Guggulu 500 mg Tab TID Mamajjaka Ghana Vati 500 mg TID Each medicine Before meal for 90 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of either gender in the age group of 25-65years.
2. Patients with classical signs and symptoms of Prameh/Madhumeha viz Prabhuta
Mutrata, Avila Mutrata, Pipasadhikya, Alasya, Utsahahani, Kshudhadhikya,
Pindikodveshthana, Karapadatala Suptata, Daurbalya, Nidradhikya and
Purishabadhdhata.
3. Patients with random blood sugar level (RBS)>200 mg/dl up to 450
4. Fasting blood sugar (FBS) >110 mg/dl up to 300 mg/dl
5. Postprandial blood sugar (PPBS) >140 mg/dl up to 450 mg/dl
6. Glycosylated haemoglobin > 6.5%.
7. Newly /early diagnosed cases to be included as per following criteria:
i. Patients who are not taking any conventional medicine for more than two
months, whose sugar levels are raised and fall within the inclusive criteria
mentioned above and are willing to take Ayurvedic treatment.
ii. Patient accidently diagnosed in routine check-up or when appeared with other
complaints in the hospital.
iii. Early diagnosed diabetic patients (less than 2yr of diabetic history) and not
taking any pharmacological drugs since last two months 
 
ExclusionCriteria 
Details  1. Patients having insulin dependent DM (type 1) and receiving insulin / OHA
2. Excessive blood glucose: FBS > 300 mg/dl and PPBS> 450 mg/dl
3. Emergency conditions in cases of DM.
4. Patients with acute/chronic liver disease with elevated liver enzymes.
5. Chronic complications like microvascular and macrovascular derangements.
6. Hyperthyroidism or hypothyroidism
7. Patients reporting to be hypersensitive to any of the proposed trial drugs.
8. Pregnant women/ lactating mothers
9. Participation in other clinical studies in past 12 weeks.
10. Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Blood sugar fasting
2. Post Prandial Blood Sugar Level 
0th day, 91st day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Glycosylated haemoglobin (in %) – HbA1C
2. Quality of life
3. Ayurveda parameters such as Roga Bala, Agni Bala, Deha Bala, Chetas Bala
4. Reduction in the classical signs and symptoms of Prameha/ Madhumeha.
5. Urine routine and microscopic examination – albumin, sugar, casts/ crystals, epithelial cells,
pus cells. 
0th day, 91st day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 4 
Date of First Enrollment (India)   23/04/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response (Others) -  Provided I get due credit

  5. By what mechanism will data be made available?
    Response (Others) -  on request subject to institutional consent

  6. For how long will this data be available start date provided 23-01-2023 and end date provided 20-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Introduction:
Diabetes mellitus, a life style disease affecting 8.3% of the adult population of the world and increasing at an alarming rate, is one of the most common non-communicable diseases of current era. The burden of this disease is immense owing to transition in lifestyle and dietary habits, ageing of the population and urbanization in the setting of a genetically predisposed environment. The prevalence of diabetes in India has remained at 11.8% in the last four years, according to the National Diabetes and Diabetic Retinopathy Survey report released by the health and family welfare ministry. The World Health Organization (WHO) estimated the global prevalence of diabetes among adults over 18 years of age as 8.5% in 2014. There are estimated 72.96 million cases of diabetes in adult population of India. The prevalence in urban areas ranges between 10.9% and 14.2% and prevalence in rural India was 3.0-7.8% among population aged 20 years and above with a much higher prevalence among individuals aged over 50 years (INDIAB Study). The term ‘Prameha’ is originated from two words, ‘Pra’ means abundant, and ‘Meha’ means ‘To pass the large quantity of Urine’. The main presenting symptom of the disease is excess and sweet urine. The complex nature of ‘Prameha’ was well understood in the ancient time, hence the disease is included in the â€˜Maha Roga’. Unlike other diseases which have usually one type of pathogenesis, Prameha/Madhumeha has four different pathogenesis. Although, Prameha is classification of diseases presenting with polyuria, in practice, often it equated with Diabetes owing to its high incidence. Never the less it is also called as Madhumeha. Prabhutatva and Avilatva are the two cardinal features of Pramehas. Prameha is a complex syndrome encompassing Obesity, Metabolic Syndrome and Diabetes Mellitus. All Prameha ultimately convert into Madhumeha. Thus, Madhumeha is an advanced stage of Prameha. The terms Prameha and Madhumeha are to be considered synonymous in context of diabetes. Ayurveda considers Prameha, as a disease of Medadhatu (Body Fats or adipose tissue) Dushti with additional derangement in Mansadhatu (muscle tissue), Kleda, Rasadhatu, Raktadhatu, Majja, Shukra etc. Ayurvedic line of Treatment starts from correction of Medadhatu Dushti (Deranged Adipose Tissue), which is responsible for further Pathophysiology of Prameha.

Methodology:
TYPE OF STUDY DESIGN: Pre and Post Study Design
SETTING: The OPDs’ and IPDs’, AIIA
RESEARCH DESIGN: Intervention
ALIGNMENT: Double Arm
SAMPLE POPULATION : Patients from institutional hospital
ALLOCATION METHOD: Non-Randomised
MASKING: Open label
SAMPLE CLASSIFICATION
Group A: 30 (Including 20% Drop Out)
Group B: 50 (Including 20% Drop Out)

AIMS:
Evaluation of the effect by Holistic approach of Ayurveda protocol in
(i) Reduction in BSL
(ii) Improving quality of life in DMT2 patients.
OBJECTIVES:
The objectives of conducting this study are:
Primary objectives:
1Assessment of the hypoglycemic effect using holistic approach of Ayurveda protocol
in newly diagnosed diabetes mellitus type 2 patients by estimating the levels of FBS,
PPBS.
Secondary objectives:
The following are the secondary objectives –
1. HbA1C (First at Baseline and 2nd after 3 Months)
To determine the Quality of Life in DM Type 2 patients
2. To evaluate in terms of Ayurveda parameters, such as Roga Bala, Agni Bala, Deha
Bala, Chetas Bala.

 
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