Evaluation of the Comparative Efficacy of Navak Guggulu Versus Vachaharidradi Gana Vati in the Management of Sthaulya (Overweight) in Children: Protocol for a Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND: Childhood obesity is a lifestyle-oriented disorder, which may lead to many comorbidities such as hypertension, coronary diseases, increased incidence of diabetes, and metabolic syndromes. Lack of diet control and increased screen time specifically after the COVID-19 pandemic among children and adolescents are the major reasons for this rising global concern. Despite various campaigns being carried out to lessen the rising rates of childhood obesity, the objectives have not yet been achieved. Ayurveda offers a multidimensional modality in managing children with overweight. The purpose of this study is to evaluate the combined efficacy of Ayurvedic medicine administration, diet restriction, and Sun Salutation. Navak Guggulu is a herbo-mineral compound already proven for its antiobesity action. Vachaharidradi Gana mentioned in Ayurvedic classics is a group of herbs, which are Kaphamedohara and Karshana. Ayurveda also emphasizes the importance of diet and physical activities for the treatment of obesity. The interventions together may help in promoting a healthy weight, improving metabolism, and reducing fat accumulation. So, in this study, the efficacy of Vachaharidradi Gana Vati will be compared with Navak Guggulu to treat children with overweight in addition to diet restrictions and Sun Salutation. OBJECTIVE: The aim of the study is to evaluate the efficacy of Navak Guggulu versus Vachaharidradi Gana Vati along with diet restriction and Sun Salutation in overweight (Sthaulya) children. METHODS: A double-blind randomized interventional study will be conducted on selected children with overweight in the age group of 10 to 16 years. They will be equally distributed into 2 groups. The control group will be given Navak Guggulu, and the trial group will be given Vachaharidradi Gana Vati for 90 days. Both groups will be advised of diet restrictions and the daily performance of the Sun Salutation. The study duration is 180 days, with assessment at baseline, followed by every 15 days up to 90 days, and at the end point, that is, after 180 days. Appropriate statistical techniques, such as analysis of covariance paired 2-tailed t test, Wilcoxon signed rank test, Mann-Whitney U test, and multivariate regression analysis, will be used to evaluate the efficacy of the interventions. RESULTS: The study got underway in April 2024. Since participants may begin at any time, our goal is for everyone to be finished by May 2025. CONCLUSIONS: This research will be useful to provide new insight into the effectiveness of the Ayurveda pharmacological approach in treating obesity in children. The results will guide evidence-based multimodality in treatments aimed at changing lifestyle behaviors in children with obesity, thus reducing social stigmatization in them. TRIAL REGISTRATION: Clinical Trial Registry of India CTRI/2023/03/051135; https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=NzgzNzE=&Enc=&userName=. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/58838.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.016 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".