Hypoglycemic Effect Using Ayurveda Treatment For The Management Of Madhumeha(Diabetes Mellitus Type 2)

Phase 4

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: Diabetes Mellitus Type 2,

• Registration Number: CTRI/2021/01/030636
• Lead Sponsor: All India Institute of Ayurveda

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-23
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients of either gender in the age group of 25-65years.
• 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.
• 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.
• Glycosylated haemoglobin > 6.5%.
• 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.
• Patient accidently diagnosed in routine check-up or when appeared with other complaints in the hospital.
• Early diagnosed diabetic patients (less than 2yr of diabetic history) and not taking any pharmacological drugs since last two months.

Exclusion Criteria

• 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.
• Patients with acute/chronic liver disease with elevated liver enzymes.
• Patients reporting to be hypersensitive to any of the proposed trial drugs.
• Pregnant women/ lactating mothers 9.
• Takes psychotropic medications that raise blood glucose (e.g. atypical antipsychotics).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Blood sugar fasting	0th day, 91st day
2. Post Prandial Blood Sugar Level	0th day, 91st day

Secondary Outcome Measures

Name	Time	Method
1. Glycosylated haemoglobin (in %) – HbA1C	2. Quality of life

Trial Locations

Locations (1)

All India Institute of Ayurveda; 🇮🇳 West, DELHI, India

All India Institute of Ayurveda

🇮🇳West, DELHI, India

Dr Kundan Wasnik

Principal investigator

9175073644

kundanwasnik@gmail.com