Study to evaluate the comparative efficacy of Navak Guggulu and Triphala Guggulu in the Management of Sthaulya (Obesity) in Adolescent

Phase 4

Not yet recruiting

Conditions: Overweight. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA),

Registration Number: CTRI/2021/05/033598

Lead Sponsor: Guru Ravidas Ayurved University Hoshiarpur Punjab

Brief Summary: *Sthaulya*(Obesity) is one among the major diseases of modern era. It is considered as s*antarpan janya vikar* (An excessnutritional disorder) in *Ayurveda*. *Sthaulya* is caused due to *medovriddhi*whichincludes abnormal and excessive accumulation of *medadhatu* in the body. This is caused by frequent and excessiveintake of *madhur* and *snigdhaaahar* , lack of physical andmental exercises. These all results into the increase in *kapha dosha* and *medodhatu*results in the *sthaulya.* It is creating an enormoussocioeconomic and public health burden in poorer countries. At least 2.6 million people each year die as a result of being overweightor obese. According to the W.H.O. overweight and obesity is thefifth leading risk for global deaths. TheInternational Association for the Study of Obesity (IASO) and InternationalObesity Task Force (IOTF) estimate that 200 million school children are eitheroverweight or obese. The proportion ofchildren who are overweight and obese has doubled over the past two decades inboth developed and developing countries, including India. Adolescence with its stormy period of rapid growth has itsown peculiar set of physical, mental and psychosocial problems. In India,adolescents constitute about 22% of the total population. With growingrealization of their vital role in the future of the nation and the society, alot of interest is generated of late, in the hitherto untreated area ofadolescent health.

Among physicalchallenges of this age group, obesity is at the top with prevalence of 8 to 15%.Asian and particularly Indian population is proved to begenetically more predisposed to obesity. The long-lasting and direconsequences of obesity, in the form of hypertension, diabetes, dyslipidemiatogether make the deadly quartet with its high morbidity and mortality. In addition, obesity brings with it many psycho-social consequences such as:Lack of self-esteem, feeling of guilt, shyness, behavioral problems, eatingdisorders, anxiety, depression etc. In practice the treatmentof obesity in adolescents can be challenging and frustrating because offrequent relapses. For the purpose of management of obesity, currently thereare two options viz. lifestyle management and pharmacological therapy. Howeverlifestyle change is the main pillar of obesity management but in practice, mostof the times it becomes difficult to achieve the goals of therapy withlifestyle changes alone. Moreover limiting energy intake of growing childrencan result in decreased linear growth velocity in obese children. Dieting couldalso increase prevalence of inadequate nutrients, such as iron, calcium, zincetc. Medical therapeutic options for treatment of obesity are not verypromising and are also associated with serious cardiovascular and othermetabolic side effects.

In the pathology of *Sthaulya*, *Kapha* is main *Dosha* and *Meda* is main *Dushya,* while *Agnimandya*takes place at *Medodhatvagni* level. So, the drugs which have *Kapha* and *Medanashaka property* possess the *efficacy to correct the function ofMedodhatv Agnimandya* are supposed to be effective in this condition*.* In *NavakaGuggulu* and *Triphala Guggulu*maximum ingredient fulfill these prerequisite properties.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1)Individuals of both genders between age group of 11 to 17 years.
2)Individuals having BMI >23 3)Individuals having classical sign and symptoms of Sthaulya like Chala Udara, Stana, Sphika (Visible Movement in Hip-Abdomen-Breast), Durbalata (weakness), Atikshudha (Excess Hunger), Atitrishna (Excess Thirst), Angagaurava (heaviness in body) etc.
4)Individuals who are willing and able to participate for 12 weeks of duration.

Exclusion Criteria

1.Individuals below 11 year and above 17 years of age.
2.Subjects receiving drugs like steroids and anti depressants etc.
Subjects having obesity due to endocrinal disorders like hypothyroidism etc.
Subjects with other co-morbid conditions like depression, diabetes mellitus etc.
5.Subjects with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal dysfunction (defined as S.
Creatinine>1.2 mg/dl) 6.Subjects suffering from major systemic illness necessitating long term drug treatment (R.A, PTB, malignancy etc.) 7.
Already known hypersensitivity to interventional drug.
8.Subjects not willing for trial.
Subjects who have participated in any clinical trial during past 6 months.
10.Any other condition which the Investigator thinks may compromise the safety of the subject.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in BMI from baseline to 12 week.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body weight from baseline to 12 week.	.â€¢ Changes in body fat percentage and visceral body fat from baseline to 12 week.

Trial Locations

Locations (1): Rajiv Gandhi Government Postgraduate Ayurvedic College And Hospital
🇮🇳
Kangra, HIMACHAL PRADESH, India
Rajiv Gandhi Government Postgraduate Ayurvedic College And Hospital
🇮🇳Kangra, HIMACHAL PRADESH, India
Dr Minakshi
Principal investigator
9418017565
drminakshi2050@gmail.com