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CTRI Number  CTRI/2024/06/069623 [Registered on: 27/06/2024] Trial Registered Prospectively
Last Modified On: 03/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relation between role of Obesity in pubertal growth and early menarche among school going female children in Madurai district. 
Scientific Title of Study   Association of Obesity in pubertal growth and early menarche among school going female children in Madurai district-A Cross sectional study. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr N Sabana yasmine  
Designation  PG SCHOLAR 
Affiliation  National Institute of Siddha 
Address  Room no 16/17,Department of Kuzhandhai Maruthuvam ,National Institute of Siddha,Tambaram Sanatorium,Chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9600876457  
Fax    
Email  sabanayasmine2020@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Suresh  
Designation  Associate Professor  
Affiliation  National Institute of Siddha  
Address  Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962571137  
Fax    
Email  drsureshherbal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Suresh  
Designation  Associate Professor  
Affiliation  National Institute of Siddha  
Address  Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha,Tambaram Sanatorium,chennai-47

Kancheepuram
TAMIL NADU
600047
India 
Phone  9962571137  
Fax    
Email  drsureshherbal@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha,Tambaram Sanatorium,Chennai-47 
 
Primary Sponsor  
Name  National Institute of Siddha  
Address  Room no 16/17,Department of Kuzhandhai Maruthuvam,National Institute of Siddha , Tambaram Sanatorium, Chennai-47 Kancheepuram. 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr N Sabana yasmine  Schools in Madurai District  MADURAI DISTRICT Zone 1- one of the Primary and secondary schools in Goripalayam. Zone 2- one of the primary and secondary schools in tallakulam. Zone 3- one of the primary and secondary schools in uthangudi. Zone 4- one of the primary and secondary schools in theppakulam.
Madurai
TAMIL NADU 
9600876457

sabanayasmine2020@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
District Educational Officer, Madurai district .  Approved 
Institutional Ethics Committee, National Institute of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  obesity and Early menarche  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Female 
Details  1.Girls of age group 8years to 12 years
2.School going girls attained menarche  
 
ExclusionCriteria 
Details  1.Presence of any associated severe systematic illness.
2.Presence of pelvic pathology such as chronic pelvic infection,pelvic endometriosis.
3.Actively taken any medication for other health problems. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The relation between the association of obesity in pubertal growth and early menarche among school going female children in Madurai district will be reported  Getting approval from screening IEC at NIS -1 months
Study commencement and conduct of the study – 4 months
Data compilation and analysis of data – 15 days
Submission of report and publication – 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="184"
Sample Size from India="184" 
Final Enrollment numbers achieved (Total)= "184"
Final Enrollment numbers achieved (India)="184" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/07/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

BACKGROUND :                       

Obesity is a major public health problem that has grown to epidemic proportions throughout the world. Rates in adults range from 10 to 25% in most Western European countries and from 20 to 25% in some parts of the United States. In children and adolescents, the National Health and Nutrition Examination Survey (NHANES III) reported an estimated 20% prevalence of obesity, defined as a body mass index (BMI) greater than 85th percentile. For all age groups and degrees of obesity ,girls are higher risk than boys.  

Obesity is not restricted to a single ethic, age, or socioeconomic group, although cultural, environmental, and genetic factors clearly play a role. The environmental factors that contribute to the development of a high degree of body fatness early in life include a high proportion of sedentary activities (eg, TV viewing), low proportion of physical activity, and a shift in diet towards more fast foods with high fat and calorie content. Among the genetic factors, polymorphism or mutations in any of the following genes may be involved in the pathophysiology of obesity

Leptin is a protein product of the obesity (ob) gene. It is secreted as a hormone mainly from white adipose tissue and serves as a signal for the brain of the body’s energy stores .By reducing food intake and increasing thermogenesis, leptin controls body fat tissue and, hence, body weight. Studies of its physiologic action in humans have shown a strong positive correlation between serum leptin concentrations and the percentage of body fat. Severe obesity is associated with a higher likelihood of continued overweight. This risk is much higher in children with obese parents. Studies have shown that parental obesity is the most important risk factor of obesity in children, owing to both the genetic influence and the shared environment (lifestyle, nutritional habits, food preferences, etc). 

Several critical periods in childhood have been identified in the development and persistence of obesity. In the gestational period, there is a direct association of high birth weight with subsequent adiposity. Thereafter, in the first year of life, children undergo changes in nutritional behavior which may influence adiposity in later life. Another crucial period is ages of 5-8 years, where adiposity increases after its nadir in childhood (‘adiposity rebound’). An early adiposity rebound may serve an index of further obesity. The final risk period for the development of persistent obesity is adolescence. 

 The observation that overweight girls tend to mature earlier than lean girls has led to the hypothesis that the degree of body fatness may trigger the neuroendocrine events that lead to the onset of menses .obesity, as measured by BMI, A correlation was also found between age at adiposity rebound and age at menarche, As obese children have higher leptin levels than lean children, this may be an important factor in their earlier onset of puberty

OBJECTIVE :

                      To determine the association of obesity in pubertal growth and early menarche among school going female children in Madurai district.

STUDY DESIGN:

            This is an Cross Sectional Study of Randomized Sampling method will be held for 6 months on Association of obesity in pubertal growth and early menarche among school going female children in Madurai district with 184 participants and her parent and to whom a questionnaire regarding the study and obtaining proper consent form, assent  form from the parent. participants who have Presence of any associated severe systematic illness ,Presence of pelvic pathology such as chronic pelvic infection, pelvic endometriosis, Actively taken any medications for other health problems  will be excluded from the study.

OUTCOME:

The Relation between the association of obesity in pubertal growth and early menarche among school going children in Madurai District will be reported.

RESULTS AND DISCUSSION:

            The results will be statistically analysed and reported.

KEYWORDS:

            Obesity, Early Menarche.

 

 
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