Efficacy of Triphaladi Ghana Vati, Udvartana and lifestyle modification in the
management of Sthaulya (overweight) in children
Scientific Title of Study
Efficacy of Triphaladi Ghana Vati, Udvartana and lifestyle modification in the
management of Sthaulya (overweight) in children - An open labelled
randomized placebo controlled clinical trial
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Anita Yadav
Designation
MD Scholar
Affiliation
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Department of Kaumarbhritya 5th floor ITRA Jamnagar
Gujarat
361008
India
Jamnagar GUJARAT 361008 India
Phone
7073914239
Fax
Email
yadavanitaa6@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sagar M Bhinde
Designation
Assistant Professor
Affiliation
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Department of Kaumarbhritya 5th floor ITRA Jamnagar
Gujarat
361008
India
Jamnagar GUJARAT 361008 India
Phone
9662512158
Fax
Email
sgrbhinde@gmail.com
Details of Contact Person Public Query
Name
Dr Sagar M Bhinde
Designation
Assistant Professor
Affiliation
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Department of Kaumarbhritya 5th floor ITRA Jamnagar
Gujarat
361008
India
Jamnagar GUJARAT 361008 India
Phone
9662512158
Fax
Email
sgrbhinde@gmail.com
Source of Monetary or Material Support
Dept. of Kaumarbhritya, 5th floor, Institute Building, ITRA, Jamnagar
Primary Sponsor
Name
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Opposite Reliance smart ITRA Jamnagar
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
Anita Yadav
PG Hospital Institute of Teaching and Research in Ayurveda
OPD no 15, OPD Building, Institute of Teaching and Research in Ayurveda Jamnagar GUJARAT
7073914239
yadavanitaa6@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Institutional Ethics Committee Institute of Teaching and Research in Ayurveda Jamnagar
(Procedure Reference: Astanga Hridya Sutra Sathana 2/14, Procedure details: Udvartana with Yava Kulattha (dry powder) Churna will be done in the Pratiloma direction for 20min. daily in the morning or evening empty stomach for the Initial 15 days.)
2
Intervention Arm
Lifestyle
-
-
Dinacarya: Patients will be asked to schedule their wake-up time between 6 am to 7 am (irrespective of
their school timing). Brushing the teeth, evacuation of Mala, bath should do every morning.
25 to 30 minut, Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Cereals:
Kodrava, Yava (Barley), Rice flakes, Oats, Ragi, Suji
(Semolina), Puffed rice, Bajara (Millets), Jowar
(Sorghum).Pulses:
Moongdal (Green gram), Rajma (Kidney beans),
Chanak (Chick peas), Masoordal (Lentils), Kulattha
(Horse gram), Matar (Pea), Arhara (Pigeon peas).
Vegetables:
Raja Kshvaka (Pumpkin), Patola (Pointed gourd), Lauki
(Ridge gourd), Karela (Bitter gourd), Paalak (Spinach),
Broccoli, Brinjal, Mulaka (Radish), Grunjanaka (Carrot),Cabbage, Cucumber, Mushroom, Cauliflo, Apathya:Godhuma, Naveen dhanya.
Masha, Tila
Potato, Street foods, Fast foods,
Chips, Namkeens, Biscuits,
Samosa, Kachori
Chocolates, Toffies, Mithai and all
excess sugar containing items.
Pizza, Burger, French fries,
Sandwich, etc
Cold Drinks, Soda, Packaged and
Canned Milk Shakes & Juices.
Curd, Paneer, Tea & Coffee,
Bakery Products
1. Children aged between 10-16 years, irrespective
of gender.
2. Individuals having BMI between 85th to 95th
percentile of CDC growth charts.
3. Individuals with any 4 classical signs and
symptoms of Sthaulya i.e., Chala Sphika Udara
Stana, Aalasya/Utsah hani, Kshudra shwasa/
Aayasen shwasa, Nidraadhikya, Swedaadhikya,
Daurgandhya, Atipipasa, Atikshudha.
ExclusionCriteria
Details
Children who are known cases of any systemic, endocrinal illness like Diabetes Mellitus
(Type-1), Thyroid disorders, Hypertension, Coronary Heart Disease (CHD), Asthma etc.
or known cases of any psychiatric or genetic disorders.
• Children who are known case of drug induced obesity and taking such drugs at present as well
Method of Generating Random Sequence
Other
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT)
✓ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid
and in classical signs and symptoms of Sthaulya. (BT and AT)
Primary Outcome: Change in the BMI and S. Adiponectin. (BT and AT)
✓ Secondary Outcome: Changes in anthropometric measurements (every 7 days), S. lipid
and in classical signs and symptoms of Sthaulya. (BT and AT)
Secondary Outcome
Outcome
TimePoints
Changes in anthropometric measurements (every 7 days), S. lipid
and in classical signs and symptoms of Sthaulya. (BT and AT)
8 wks
Target Sample Size
Total Sample Size="40" Sample Size from India="40" 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 3
Date of First Enrollment (India)
05/05/2023
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="2" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
yet not published
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Introduction: Childhood overweight is growing in leaps and bounds, and becoming an epidemic health problem across the globe. It is pioneer to many lifestyle disorder. Thus, apart from malnutrition, overweight is a new rising concern in India. It is the new emerging epidemic that needs to be taken cared well in time. Significance: In the contemporary science there are only few treatment modalities for overweight like weight loss drugs (Hyroxycut, Meratrim and Orlistat), bariatric surgery (liposuction) and lifestyle interventions (diet and exercise). However, others except lifestyle intervention have known side effects. Because of limitations and inconsistency in tackling this problem, and the complications associated with contemporary health care system, this research topic has been selected. Ayurveda has mentioned detailed management of overweight under the heading of Sthaulya and Santarpanotha Vyadhi. Ayurveda treatment comprises Shamana as well as Shodhana therapy along with lifestyle modification. Various researches have also shown promising results with the help of these Ayurveda treatments in overweight children. Aim and Objectives: To evaluate the efficacy of Triphaladi Ghana Vati, Udvartana and lifestyle modification, in the management of Sthaulya (overweight) in children. Materials and Methods: 40 Children of either sex aged between 10-16 years with any 4 classical signs and symptoms of Sthaulya i.e., Chala Sphika Udara Stana, Aalasya/Utsah hani, Kshudra shwasa/ Aayasen shwasa, Nidraadhikya, Swedaadhikya, Daurgandhya, Atipipasa, Atikshudha will be enrolled in two groups. Group A: Trial group: Triphaladi Ghana Vati internal; Udvartana with Yava Kulattha, and life style modification. Group B: Placebo control group: Placebo drug and life style modification Results and Discussion: Data generated during the above study will be presented in a systemic manner and shall be analyzed statistically. Follow up: After completion of therapy, follow up will be done for 4 weeks (visit in every 15 days) to assess the status of patient, where the patient will be asked to report. Adverse effects: This proposal will be reviewed and approved by ITRA, Institutional Ethics Committee, which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not aware of. Adverse drug reactions if any observed will be reported to the Pharmacovigilance cell of ITRA.