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Clinical Trials/CTRI/2024/03/064827
CTRI/2024/03/064827Not yet recruitingPhase 2/3

Effect of Khadira (Acacia catechu Linn.) saara churna in the management of Medodushti w.s.r to Overweight and Obese individuals - An open labelled clinical trial

Dr Santhosh N1 site in 1 country30 target enrollmentStarted: April 20, 2024Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Weight loss

Study Overview

Brief Summary

Obesity is a serious and highly prevalant disease assosciated with increased morbidity and mortality. A thorough medical assessment is required to identify patients who are obese or at risk of obesity or obesity related complications. Considering Statistical data points, the number of obese individuals world is on ascent. As on 2022 information of WHO more than 1 billion individulas overall are obese, in that 650 million are grown ups, 340 million are teenagers and 39 million are youngsters. In India 135 million people were impacted by copulence.

The commonness of obesity in India differs because of Age, Orientation, Tophographical climate, Financial status, and so on. WHO gauges that by 2025, around 167 million adults and kids will turn out to be less healthy as a result of obesity. In the classes of obesity, Overweight and Class one oobesity is more prevalant amongst population. 

In ayurveda classics Medodushti is pathological event which causes sthoulya and atisthoulya, which comes underAshtanindita. Both the words Medovriddhi(Sthoulya) and Medo dushti are used as synonyms of each other. Medo dushti is also root cause for hazardous complications viz, Hridroga and Prameha. The Khadira is explained by Acharya Sushruta under Saalasaaradi ghana and their saara as useful part. The properties of Saalasaraadi ghana are "Mehapanduaamayahara Kaphamedovishoshana".

Bhavaprakasha explains the drug Khadira as "Tikta Kashaya Medhogna krumi meha jwara Vranaahareth" which means the drug efficiently reduces excessive meda.

Building Certainity on sungle drug therapy and minimal expense with high compelling treatment is need of great importance. Keeping this in View single drug therapy with compelling dose w.s.r to Khadira (Acacia cathechu Linn) Saara is considered for the ongoing review.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 50.00 Year(s) (—)
Sex
Male

Inclusion Criteria

  • Male individuals of BMI above 25 to below 35 Male individuals aged between 18 to 50 years fulfilling diagnostic criterias.

Exclusion Criteria

  • Patients having BMI below 25 and above 35 Female Individuals Patients having age less than 18 years and more than 50 years Patients having systemic disorders like, Hypertension, diabetes mellitus, Thyroidism etc.

Outcomes

Primary Outcomes

Weight loss

Time Frame: 0th, 21st, 42nd

Secondary Outcomes

  • Reduction in skin fold thickness in Middle portion of biceps and triceps muscle, Anterior surfeace of mid thigh region, Abdominal muscle at umbilicus, Subscapular region.(Anthropmetric changes in Neck, Abdomen, Mid arm, Waist, Mid thigh)

Investigators

Sponsor
Dr Santhosh N
Sponsor Class
Other [Self sponsored pg dissertation work]
Responsible Party
Principal Investigator
Principal Investigator

Dr Santhosh N

KAHERS Shri BMK Ayurveda college

Study Sites (1)

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