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CTRI Number  CTRI/2021/05/033598 [Registered on: 13/05/2021] Trial Registered Prospectively
Last Modified On: 10/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to evaluate the comparative efficacy of Navak Guggulu and Triphala Guggulu in the Management of Sthaulya (Obesity) in Adolescent  
Scientific Title of Study   A Randomized Clinical Study to Evaluate the Comparative Efficacy of Navak Guggulu and Triphala Guggulu in the Management of Sthaulya (Obesity) in Adolescent 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Professor Rakesh Sharma 
Designation  Dean Colleges  
Affiliation  Guru Ravidas Ayurved University Hoshiarpur  
Address  Dean Colleges Department of Kayachikitsha Guru Ravidas Ayurved University Hoshiarpur Punjab
Dean Colleges Department of Kayachikitsha Guru Ravidas Ayurved University Hoshiarpur Punjab
Hoshiarpur
PUNJAB
146001
India 
Phone  9814779242  
Fax    
Email  deangrauh@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Minakshi  
Designation  Senior Lecturer 
Affiliation  RGGPGA college Paprola  
Address  Department of Kaumarbhritya RGGPGA college and hospital Paprola district Kangra Himachal Pradesh
RGGPGA college and hospital paprola district Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India 
Phone  09418017565  
Fax    
Email  drminakshi2050@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Minakshi  
Designation  Senior Lecturer 
Affiliation  RGGPGA college Paprola  
Address  Department of Kaumarbhritya RGGPGA college and hospital Paprola district Kangra Himachal Pradesh
RGGPGA college and hospital paprola district Kangra Himachal Pradesh
Kangra
HIMACHAL PRADESH
176115
India 
Phone  09418017565  
Fax    
Email  drminakshi2050@gmail.com  
 
Source of Monetary or Material Support  
Guru Ravidas Ayurved University Hoshiarpura Punjab 
 
Primary Sponsor  
Name  Guru Ravidas Ayurved University Hoshiarpur Punjab  
Address  Guru Ravidas Ayurved University Hoshiarpur Punjab 
Type of Sponsor  Government medical college 
 
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 Minakshi   Rajiv Gandhi Government Postgraduate Ayurvedic College And Hospital  Department of kayachikitsha and kaumarbhritya VPO Paprola District Kangra Himachal Pradesh 176115
Kangra
HIMACHAL PRADESH 
9418017565

drminakshi2050@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Guru Ravidas Ayurved University Hoshiarpur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAM (KEVALA-KAPHA),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Navak Guggulu  500mg, two tablets twice a day with Luke warm water orally for 12 weeks 
Comparator Agent  Triphala Guggulu  500mg, two tablets twice a day with Luke warm water orally for 12 weeks  
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  17.00 Year(s)
Gender  Both 
Details  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.

 
 
ExclusionCriteria 
Details  1. Individuals below 11 year and above 17 years of age.
2. Subjects receiving drugs like steroids and anti depressants etc.
3. Subjects having obesity due to endocrinal disorders like hypothyroidism etc.
4. 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.
9. 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.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in BMI from baseline to 12 week.   12 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in body weight from baseline to 12 week.
.• Changes in body fat percentage and visceral body fat from baseline to 12 week.
•Changes in Waist-Hip Ratio from baseline to 12 week.
•Changes in Skin Fold Thickness from baseline to 12 week.
 
12 week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/05/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not available 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sthaulya (Obesity) is one among the major diseases of modern era. It is considered as santarpan janya vikar (An excess nutritional disorder) in Ayurveda. Sthaulya is caused due to medovriddhi which includes abnormal and excessive accumulation of medadhatu in the body. This is caused by frequent and excessive intake of madhur and snigdhaaahar , lack of physical and mental exercises. These all results into the increase in kapha dosha and  medodhatu results in the sthaulya.  It is creating an enormous socioeconomic and public health burden in poorer countries. At least 2.6 million people each year die as a result of being overweight or obese. According to the W.H.O. overweight and obesity is the fifth leading risk for global deaths. The International Association for the Study of Obesity (IASO) and International Obesity Task Force (IOTF) estimate that 200 million school children are either overweight or obese. The proportion of children who are overweight and obese has doubled over the past two decades in both developed and developing countries, including India. Adolescence with its stormy period of rapid growth has its own peculiar set of physical, mental and psychosocial problems. In India, adolescents constitute about 22% of the total population. With growing realization of their vital role in the future of the nation and the society, a lot of interest is generated of late, in the hitherto untreated area of adolescent health.

Among physical challenges of this age group, obesity is at the top with prevalence of 8 to 15 %. Asian and particularly Indian population is proved to be genetically more predisposed to obesity. The long-lasting and dire consequences of obesity, in the form of hypertension, diabetes, dyslipidemia together 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, eating disorders, anxiety, depression etc. In practice the treatment of  obesity in adolescents  can be challenging and frustrating because of frequent relapses. For the purpose of management of obesity, currently there are two options viz. lifestyle management and pharmacological therapy. However lifestyle change is the main pillar of obesity management but in practice, most of the times it becomes difficult to achieve the goals of therapy with lifestyle changes alone. Moreover limiting energy intake of growing children can result in decreased linear growth velocity in obese children. Dieting could also increase prevalence of inadequate nutrients, such as iron, calcium, zinc etc. Medical therapeutic options for treatment of obesity are not very promising and are also associated with serious cardiovascular and other metabolic 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 of Medodhatv Agnimandya are supposed to be effective in this condition. In Navaka Guggulu and Triphala Guggulu maximum ingredient fulfill these prerequisite properties. 

 
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