Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 26, 2024
Open Peer Review Period: Mar 27, 2024 - May 22, 2024
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Evaluation of comparative efficacy of Navak Guggulu as against Vachaharidradi Gana Vati in the management of Sthaulya (Overweight) in children: A Randomized Controlled Trial
ABSTRACT
Background:
Background:
Urbanization & industrialization is contributing to the change in the lifestyle and food preferences especially in children. Childhood obesity is mainly a lifestyle-oriented disorder. It is a rising global burden with its lifelong implications. If not treated in childhood period, it may land up in adulthood with serious complications. In Ayurveda, Sthaulya is the condition which can be referred to obesity. Being over-obese is termed as Atisthula which is a santarpanottha (overnutrition) vyadhi (disorder) and is counted under eight censurable physiques. Treatment of Sthaulya is Karshana (Therapeutic Scrapping). Navak guggulu’s efficacy is already proven for treatment of Obesity. Vachaharidradi gana is a group of Karshana herbs mentionaed in Ashtang Hriday. So, in this study the efficacy of Vachahardidradi gana vati will be compared with Navak guggulu to treat overweight children.
Objective:
Evaluation of the efficacy of Navak Guggulu along with diet restriction and Suryanamaskara versus Vachaharidradi Gana Vati along with diet restriction and Suryanamaskara in children (10 – 16 years) with Sthaulya (Overweight).
Methods:
After doing the drug analysis, a total of 86 overweight children fitting into inclusion criteria from 10 to 16 years of the age group will be selected and will be distributed in 2 groups having 43 each. One group will be trial group and other group will be control group. Control group will be given Navak Guggulu and trial group will be given Vachahardiradi gana vati tablet. The medicines will be provided to subjects in double blinding manner. Both the groups will receive medicines for 90 days along with diet restriction and Suryanamaskara and they will be followed up every 15 days and their assessment during each visit will be recorded in the case record form. Final follow-up will on 180th day.
Results:
Results will be drawn from the observations of subjective and objective parameters.
Conclusions:
Conclusion of the study will be drawn based on statistical data calculated from the collected data and overall improvement. Clinical Trial: CTRI No. - CTRI/2023/03/051135 (clinical trial registry India) Dated –28/03/2023
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