Comparative Clinical evaluation of Lekhana Basti and specific Ahara in Sthaulya(obesity)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Marked improvement: 76-100%
Study Overview
Brief Summary
Obesityis defined as excess of adipose tissue that impart health risk. Itis associated with an increased risk of multiple health problems, includingtype 2 diabetes, dyslipidemia, obstructive sleep apnea, nonalcoholic fattyliver disease, degenerative joint disease, and some malignancies.Obesity is a complex, multifactorial, and largely preventable disease,affecting, along with overweight, over one- third of the world’s populationtoday. Obesityin India has reached epidemic proportions in the 21st century withmorbid obesity affecting 5% of the country’s population. The mostwidely used method to classify weight status and risk of disease is body massindex (BMI). In India Patient with BMI≥25kg/m2 is considered obese. Sthaulya is a Santarpana Janya Vikara causeddue to consumption of Guru, Madhura, Sheeta, SnigadhaAhara, Avayayam, Avayavaya, Diwaswapna, Harshnitya, Achintaand Beeja Dosha.AcharyaSushruta has mentioned about LekhanaBasti in management of Sthaulya, Basti is main treatment of vitiatedVayu and Lekhniya Dravya will subside the elevated Kapha andMeda so Lekhana Basti is selected for the treatment of *Sthaulya.*VadiyaLolimbraj has given a very importantprinciple regarding Pathya and Apathya. Study has been conductedon various single Ahara Dravya like Yava, Kodrava etc.which was found effective in obesity. Combination of these various AharaDravya will be more helpful in management of obesity.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patient having sign and symptoms of Sthaulya.
- •2.Patients of age 20-60 years.
- •3.Patient willing to take part in Lekhana Basti.
- •4.Patient fit for Lekhana Basti.
- •5.Patients willing to follow diet chart in Sthaulya 6.Patient with BMI 25 or greater than 25.
Exclusion Criteria
- •1.Patient having age less than 20 years and above 60 years 2.Patients having uncontrolled diabetes, uncontrolled hypothyroidism, hypertension and other life-threatening complications.
- •3.Pregnant and lactating females 4.Body Mass index of (BMI>40 kg/m2).
Outcomes
Primary Outcomes
Marked improvement: 76-100%
Time Frame: 0,15th,30th, 45th, 60th day
No improvement:0-25%
Time Frame: 0,15th,30th, 45th, 60th day
Mild improvement:26-50%
Time Frame: 0,15th,30th, 45th, 60th day
Moderate improvement:51-75%
Time Frame: 0,15th,30th, 45th, 60th day
Secondary Outcomes
- exacerbation in signs and symptoms(60th day)