Effect Of Haritaki and Dhanvayas in the Management Of Obesity

Phase 2/3

Not yet recruiting

• Conditions: Obesity, unspecified. Ayurveda Condition: MEDOROGAH,

• Registration Number: CTRI/2023/11/059848
• Lead Sponsor: Ayurvedic and Unani Tibbia College

Brief Summary

Obesity/Overweight is a global epidemic resulting from sedentary lifestyles, improvedsocioeconomic conditions and availability of processed ,high calorie foods and soft drinks inindustrialized societies. Approximately 35% of US adult population is overweight, and anadditional 30 % of adults are obese; the prevalence of obesity in children and adolescents isalso increasing indeed reaching epidemic proportions . As obesity is correlated with increasedmorbidity and mortality , it is important to define and recognize it, to understand its causesand to be able to initiate appropriate measures to prevent or manage it. Behavioral and dietarychanges are the initial therapeutics strategies; weight loss drugs are used but due to theirside effects they are used with caution. Obesity is associated with an increased riskof multiple health problems, including hypertension, type-2 Diabetes, obstructive sleepapnea , dyslipidemia ,non-alcoholic fatty liver disease, degenerative joint disease. Thusit is important for its identification, evaluation and treatment so that associatedcomorbities doesn’t occur.Worldwide obesity has nearly tripled since 1975. In 2016, more than 1.9 billion adults, 18years and older, were overweight. Of these over 650 million were obese. 39% of adults aged18 years and over were overweight in 2016, and 13% were obese. Most of the world’spopulation live in countries where overweight and obesity kills more people thanunderweight. 39 million children under the age of 5 were overweight or obese in 2020.Over340 million children and adolescents aged 5-19 were overweight or obese in 2016. Pharmacology of Ayurvedic treatment on Sthaulya based on dissolving the accumulated fatby means of shoshana like sleshma-medohara ,ushna, trikshna aahara or drugs. Thedrugs which will replinsh or scrapes away the unwanted tissues (dhatus) and metabolicwastes (malas) is known as Lekhana. In Modern anti-hypercholesterolemia or anti-obesity like drugs are found to havemany adverse effects; hence it is the need of the hour to find an alternative drug in other10systems of medicine. Although a number of research works and studies have been done onthe treatment of Sthaulya (Obesity), still there is an intense need for the effectivemanagement of this dreadful disease. In this view the study has been selected to establishanti-obesity drugs and having anti-hyperlipidemic activity by using the Haritaki(Terminaliachebula) (Roxb.) mentioned in Charak samhita under Santarpaneeya adhyaya and in Ashtanghridya under Dwividho opkramneeya adhyaya containing Sthaulyanashakproperties.Dhanvyas(Fagonia cretica{Linn.}) mentioned in Bhavprakash Nighantu havingmedovikarhar properties.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-12
• Last Update Posted: 2023-06-11

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• 1.Patients between the age group of 18-60 years of either sex.
• Willing and able to participate in the study for 90 days.
• BMI >30.00kg/m2 and BMI < 40 kg/m2.
• Patient not taking any oral conventional medicine.
• Patients having associated symptoms according to Ayurvedic classification of Sthaulya (Obesity) like Chalsphikudarstana, Swedadhikya, Atiskhudha, KshudraSwasa, Angagaurava , Anga Chalatva ,Atipipasa, Avyavaya.

Exclusion Criteria

• The patient having B.M.I. >40.
• Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, congestive heart failure, Stroke or severe Arrhythmia, Unstable angina in the last six months.
• Patients on prolonged (>6weeks) medication with corticosteroids, antidepressants, anticholinergics, immunosuppressant, estrogen replacement therapy etc.
• or anyother drugs that may have an influence on the outcome of the study and patientson oral contraceptives.
• Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mmof Hg) despite of antihypertensive agents.
• .Patients having history of diabetes i.e (HbA1c > 6.5%) 6.
• Hypothyroidism .
• Pregnancy and Lactating mother.
• Patient who has participated in any clinical trial in past 6 Months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparative evalauation of Both the drug i.e. Haritaki churna and Dhanvyas churna would be assessed on -disappearance of clinical symptoms of sthaulya as per questionaire and improvement in Lipid Profile of subjects, BMI,Subjective/Objective parameters , Girth measurements asfrom baseline and after 90 days of therapy	3 months

Secondary Outcome Measures

Name	Time	Method
Pharmacognostical and Phytochemical evalaution of the drug would be done from GMP certifiedlab.	Improvement in Health conditions as per SF-36 Health survey.

Trial Locations

Locations (1)

Ayurvedic and Unani Tibbia College and Hospital; 🇮🇳 Central, DELHI, India

Ayurvedic and Unani Tibbia College and Hospital

🇮🇳Central, DELHI, India

Dr Rajesh Sharma

Principal investigator

9868092250

rajsakshi.sharma@gmail.com