| 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
|
|
|
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
|
|
|
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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response (Others) - Provided I get due credit
- By what mechanism will data be made available?
Response (Others) - on request subject to institutional consent
- 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.
- 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 ‘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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