A Randomized Controlled Clinical Study to evaluate the efficacy of Brihat-Vridhadaruka Sama Churna and Navaka Guggulu in the management of Sthoulya w.s.r. to Obesity
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The proportion of the patient’s showing improvement in the BMI level after the participation in study.
Study Overview
Brief Summary
Obesity is defined as abnormal or excessive fat accumulation that presents a risk to health. In Ayurveda Obesity is mentioned as Sthoulya Roga. It is classified as a metabolic condition under the category of Medoroga which is caused by a malfunctioning of Medadhatvagni. In the Astoninditiya Adhyaya of Charaka Samhita, Acharya gives the definition of Sthoulya "medomam-saativrudhatwat chalasphik-udarastana Ayatha-upachayanutsaha sthaulya-itiuchyate". The world is looking to Ayurveda for a successful management strategy and obesity prevention. Because allopathic treatment of obesity such as bariatric surgery is expensive and medications have various side effects. Through certain dietary and lifestyle modifications, ayurveda has placed a strong focus on all-encompassing strategies that help people lose extra weight and maintaining it off. To help us control the condition, numerous theories and treatments have been proposed. The present study is conducted to compile the available information regarding Sthoulya, in classical literature of Ayurveda and to validate the statement of Acharyas. So here also an attempt has been made to evaluate the efficacy of Brihat Vridhadaruksama Churna with Anupana of Kanji in Sthoulya which is a Shamana Chikitsa. With limited adoption of the first line of treatment in the form of moderate exercise and dietary measures is oriented to suit the people with reasonable time and money.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1 The patient has signs and symptoms of Sthoulya explained in Ayurvedic texts.
- •2 Patients with the age group 18 – 60 years of both genders.
- •3 The patient having 10% excess weight than desirable weight according to height, sex, and age.
- •4 The patient with a BMI of 25 to 34.
- •5 Waist hip ratio: males more than 102 cm and females more than 88 cm 6 Ready to give written and informed consent.
Exclusion Criteria
- •1 The patient is below 18 years and above 60 years of age of both genders.
- •2 The patient with a BMI of 35 and more than
- •3 Patients suffering from diabetes mellitus, endocrinal disorders, cardiovascular diseases, hypertension, respiratory diseases, polycystic ovarian syndrome, and other such diseases in which the person cannot do his/her routine daily activities will be excluded.
- •4 Patients of Acute renal failure, chronic renal failure and Nephrotic syndrome.
- •5 Patients who have a known history of HIV, Hepatitis and other infectious diseases.
- •6 Patients with autoimmune disorders.
- •7 Pregnant and lactating mothers.
- •8 Alcoholics and other drug abusers.
- •9 Patient on prolonged medication with Corticosteroids, Antidepressants, Anticholinergic, Anticonvulsant, Antipsychotics, etc.
Outcomes
Primary Outcomes
The proportion of the patient’s showing improvement in the BMI level after the participation in study.
Time Frame: 60 Days
Secondary Outcomes
- 1 Change in waist- hip ratio.(2 Change in quality of life.)
Investigators
Dr Nisha
Institute for Ayurved Studies and Research