INTRODUCTION:

    Ayurveda – is a holistic health system of India derived from Sanskrit word means   knowledge/science (Veda) of life (Ayur). It is often translated as "Science of Longevity" or "Science of Life" denoting an entire traditional system of healing. Thousands of years ago, India’s Rishi and Seers observed and recorded the text about the values of herbs. These insights form the basis of Ayurveda and documented in the ancient Indian texts.

To live a healthy life, Our Acharyas described certain basic principles of Ayurveda such as Dincharya, Ritucharya, Achararasayana etc. In recent time, we have overlooked these principles of living life and mere following western culture and food habits in day to day activities resulting occurrence of several lifestyle related health problems including Sthoulya (Overweight).

Major Life style disorder like Sthoulya i.e. Overweight has emerged as big challenge for the health practitioners worldwide. In Ayurveda Text Charaka¹ - Sthoulya is described as “Ashtauninditiya Sharira” a condition wherein there will be Sharira Ayathoupchaya² associated with abnormal increase of Medodhatu and also described as Santarpanjanit Roga³.

             According to Sushruta Samhita Sutrasthan chapter 15, Sthoulya is mentioned as Rasnimittam⁴. It has been evidenced that Sthoulya is a worst condition of a particular person⁵.

Overweight is the result of modern age of machines and materialism, it occurs as a result of absence or lack of physical activities associated with increased intake of food. Industrialization, stress due to modern work culture results into a clinical entity which is called as Obesity. This condition of obesity can be diagnosed earlier i.e. overweight. Overweight is a premonitory symptom of Sthoulya.

 Sthoulya i.e. Overweight is a health condition in which excess body fat has accumulated to the extent that it may have a negative effect on health. The term overweight represents excess body weight in relation to height. It is often expressed in terms of Body Mass Index (BMI). A BMI of 25 or more indicates overweight which leads to obesity. The WHO designations include the following: Grade 1 overweight (commonly called overweight) - BMI of 25-29.9 kg/m². Grade 2 overweight (commonly called obesity) - BMI of 30-39.9 kg/m² .Grade 3 overweight (commonly called severe or morbid obesity) - BMI greater than or equal to 40 kg/m².

In Indian context, the common definitions of BMI (Kg/m2 ) (As per ICMR Hyderabad, AIIMS Delhi, Diabetic Foundation of India and National Institute of Nutrition) & ranges are - Underweight: Less than 18 Normal (Healthy and Low risk): 18 to 23 Overweight (Little Risk): 23 to 25 Obesity Gr. I (High Risk): 25 to 30 Obesity Gr. II (Very High Risk): 30 to 35 Obese Class III (Highest Risk): More than 35.

In our study, we will consider the latest BMI guidelines issued by ICMR Hyderabad, AIIMS Delhi and Diabetic Foundation of India and National Institute of Nutrition).

NEED OF STUDY -

Many International agencies including WHO, now endorsed obesity a major health concern. In last three decades it has been made evident that there is a sudden upsurge in the data on people affected with obesity worldwide. Over last three decades, despite several public health efforts, none of the country has reported decreasing rate of obesity. This means the problem is still under concern and thus not only we need to study it more but also in better way.

The modern management of Obesity with synthetic drugs, surgeries has many residual effects associated with. Natural way to address Sthoulya has been mentioned in Ayurveda. Today, there is urgent need to find out the drugs which are cost effective, easy to available and easy to administer. Keeping in view above facts and to get a way through the burning issue of overweight, it has been decided to carry out study the action of Tinospora cordifolia Willd and Cyprus rotundus Linn in Sthoulya i.e. overweight.

SELECTION OF DRUG –

In present study, we have selected well known Ayurvedic herbs Guduchi and Mustak. The roles of these herbs are already defined in the management of Sthoulya. In Charak Samhita both of these drugs are described to cure Sthoulya.

Moreover, in Lekhniya Mahakashaya⁶ of Charak, Mustak has defined as Lekhniya aushdhi. Medohar effect of Guduchi is stated in Dhanvantari Nighantu⁷ So the purpose of selection of these drugs is to analyse their action in Sthoulya.                                                                     

Textual evidence suggests that Guduchi & Mustak are effective in Sthoulya (Cha. Sutra. Chapter 21/22,  Asht. Sang. Sutra.Chapter 24/35 & Asht. Hriday Sutra. Chapter 14/22).

Experimental studies suggest Cyprus rotundus is effective in weight reduction (Lemaure B et al.)⁸ & Exp. Studies by Dhingra et al⁹ suggest anti-obesity properties of Tinospora cordifolia

Research Question: Does Guduchi & Mustak possess any significant effect in Sthoulya i.e. Overweight?

Hypothesis - Null Hypothesis: Guduchi and Mustak does not possess any significant effect in Sthoulya i.e. .Overweight.

Alternate Hypothesis: Guduchi and Mustak possess significant effect in Sthoulya i.e. Overweight.

AIMS AND OBJECTIVES:

v  To evaluate pharmacognostical and phytochemical study of Guduchi and Mustak.

v  To conduct a randomized open clinical trial in order to evaluate the action of Guduchi and Mustak in patients of Sthoulya i.e. overweight.

Materials and METHODS:

1.      Conceptual Study-

v  Review of Literature, Compilation will be performed according to Ayurvedic Samhitas, Nighantus, Botany textbooks, journals, and websites etc.

v  Review of herbal properties of Guduchi and Mustak will be carried out through classical literature of Ayurveda followed by taxonomic classification.

2.      Collection of Drug-

v  Test Drugs will be collected from proper authentic source after identification by subject experts.

3.      Manufacturing of Trial Drugs-

v   The trial drugs Guduchi stem and Mustak’s rhizomes will be used in the form of Churna.

4.      Pharmacognostical Study-

v  Organoleptic character and Phyto-chemical assessment of drug will be performed in the departmental laboratory as per the API and WHO prescribed guidelines.

    Following action/task (s) will be performed.

v  Ash Value

v  Moisture content

v  pH Value

v  TLC

5.      Clinical Study-

v  Study design - Randomized, Open Labeled and Triple Arm Clinical Trial.

v  Patients will be taken from NIA campus, OPD, Seth Surjamal Bombaiwala Hospital and Satellite Hospital Jawahar Nagar Jaipur.

The subjects found to be suffering from Sthoulya i.e. Overweight and consenting to participate in the drug trial will be selected and to be divided randomly into three groups.

Distribution of Patients with dose, duration and Bhaishjaya Kaal

20 Patients per group will be recruited in the trial. This number indicates the number of trial subject completing the trial, excluding the drop outs. So the number of recruited patients might exceed the intended sample size. They will be selected randomly.

INCLUSION CRITERIA (Criteria of Selection)

v  Patients from either sex with classical sign and symptoms of Sthoulya.

v  Patients of age group 16 - 60 years.

v  Patients with BMI more than 23 Kg/m²   - 25 Kg/m²

v  Waist to Hip ratio (Males > 0.90 and Females >0.80) according to WHO.

EXCLUSION CRITERIA

v   Patients below 16 and above 60 years of age,

v   Patients having major systemic disorders or other illnesses such as      

 Hypothyroidism, Cushing syndrome & Hypersensitivity, which interfere  

       with the present study.

v  Patients having any hereditary disposition

v  Patients with serious disease limiting life expectancy.

v  Pregnancy and lactating mothers.

WITHDRAWAL CRITERIA - If any patient develops any adverse reactions or deteriorates, he/she will be withdrawn from the trial.

Subjective parameter ¹⁰- (By Self Scoring Criteria)

v  Javoparodh (Sluggishness/Utsaha hani)

v  Daurgandhya (Foetid body odour)

v  Swedaabaadha (Excessive sweating)

v  Kshudhatimatra (Excessive hunger)

v  Pipasaatiyog (Excessive thirst)

Objective Parameters-

v  BMI

v  Waist to Hip Ratio 

v  Mid Arm &Thigh Circumference

v  Lipid Profile

Statistical Method- Data recorded will be statistically analyzed by appropriate statistical methods