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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: ATISTHAULYAMÂ (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. |