Comparison of effect of plain and processed Triphala powder in overweight and obesity of children aged 10-16 years.

Phase 1/2

Not yet recruiting

• Conditions: Overweight. Ayurveda Condition: MEDOROGAH,

• Registration Number: CTRI/2023/07/055149
• Lead Sponsor: DrVaruni P Kulkarni

Brief Summary

*Sthoulya* isa condition described under *Shleshmananatmajavyadhi* (1), *Santarpana nimittaja vyadhi*(2) and *Atibrimhananimittajavyadhi*(3). It is described as *Upachita shareeratvam*(4) and is characterized by excess accumulation of *Medas.* There are many *lakshana* of *Sthoulya(5) as* mentionedin *Ayurveda* , of which a few symptomsthat are commonly found in children are *Atinidra, Alasya, Ayase Shwasa* and *Atikshudha.*

The clinical symptomatology of *Sthoulya* is similarto that of Overweight and Obesity *in* contemporary science, which has beendefined as, a body mass index of 23kg/m2 and 27kg/m2 respectively. (Indian cutoffs after 2years of age, which is between 85th to 95thpercentile) (6) Enlargement of fat cell in its size; or anincrease in number of fat cells; or both, leads to abnormal growth of adipose tissue which is known asobesity. In such condition, body fat is extensively accumulated under the skin and around certain organs such as belly,breasts, thighs (7)

  According to a study in 2021, the prevalence ofoverweight and obesity among school children in Mysuru, Karnataka showedthat there was 3.86% of obesity and 12.27% of overweight(8). A recentstudy conducted 2021, in school children of Mysuru, Karnataka revealedsignificant differences in variablessuch as body weight and BMI, before and after lockdown. Post lockdown the BMI increasedamong all the participants from 17.32 to 17.80 kg/m2(p<0.001). The study also depicted thatobesity has a proportional impact on the children’s quality of life (QOL)(9)In a recent study done in Rishikesh ,Uttarakhand, in the year 2021,itwas found that 6.8% of adolescents were obese and that about 17.1% were overweight.(10)These studies give enough proof for the prevalence of overweight andobesity among children even in adolescent age group.

  Some of the common complications of childhood obesity,if left unattended are Obstructive sleep apnea, Asthma,Acanthosis nigricans and Polycystic ovariansyndrome and Psychological problems like Anxiety,Low self esteemand Worsening school performance (11,12). Contemporary science has a multi disciplinary approach in the management of obesity, like lifestyle modification, regular meal timingsand at least 7-8 hours of sleep at night (12)*.*

*Ayurveda* alsodescribes multi model therapy including diet, medicine and life stylemodifications for *Sthoulya*. Some of the *Shamanoushadhi* indicated for *Sthoulya* are *Triphala churna, Vidanga Churna,Vidangadhya louham* and *Navakaguggulu.*(13) Usage of *Triphala* and*Madhu* have been specifically mentioned in *Sthoulya chikitsa* in *Charaka Samhita and Ashtanga Samgraha (14)*. Accordingto the Kerala based text dealing with Kaumarabhritya viz; *Arogya Raksha Kalpa Druma*

*,Triphala* trituratedin the *Kwatha* of *Khadira* and *Asana,* consumedfor 1 month reduces *Sthoulya.* It has been specifically mentionedfor children (15). A previous clinical study conducted in the year of 2011 have shown significant resultsof *Khadira* and *Asana KwathaBhavitha Triphala* in children

of 5-15 yearswith *Sthoulya* in comparison to thecontrol group -*Pathya*.

 Based on the above references, the present study hasbeen planned to evaluate the efficacy of *Bhavita Triphala churna* in *Sthoulya* viz a viz childhood overweightand obesity in adolescent children.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-25
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Subjects from age group 10-16 years, irrespective of gender and socioeconomic status.
• 2.Obesity caused due to Exogenous factors like over-eating and poor physical activities.
• 3.Body mass index of 23kg/m2 and27kg/m2 respectively i.e. body weight between 85th -95th percentile for the selected age group.
• 4.Subjects having signs and symptoms of Sthoulya as explained in Ayurveda.
• 5.Parents ready to sign written informed consent.

Exclusion Criteria

• 1.Known cases of endocrine disorders like Hypothyroidism and Cushing’s syndrome.
• 2.Any other systemic and genetic disorders.
• 3.Drug induced obesity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of the trial drug with that of standard drug on the values of Body Mass Index Weight Skin Fold Thickness Mid upper arm circumference	6 months

Secondary Outcome Measures

Name	Time	Method
To compare the efficacy of trial & standard drugs on Health Related Quality Of Life(HRQoL) parameters	70 days

Trial Locations

Locations (1)

JSS Ayurveda Medical Hospital; 🇮🇳 Mysore, KARNATAKA, India

JSS Ayurveda Medical Hospital

🇮🇳Mysore, KARNATAKA, India

DrJyothy KB

Principal investigator

7776014076

jyothybmenon@yahoo.com