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CTRI Number  CTRI/2023/07/055149 [Registered on: 12/07/2023] Trial Registered Prospectively
Last Modified On: 11/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of effect of plain and processed Triphala powder in overweight and obesity of children aged 10-16 years. 
Scientific Title of Study   A Randomised Standard Controlled Clinical trail on Bhavitha Triphala Churna in Sthoulya vis-a-vis childhood Overweight and Obesity 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrVaruni P Kulkarni 
Designation  Second PG scholar 
Affiliation  JSS AYURVEDA MEDICAL COLLEGE, MYSURU-570028 
Address  Department of PG studies in Kaumarabhritya OPD 11 JSS Ayurveda Medical College Lalitadripuram road Mysuru 570028

Mysore
KARNATAKA
570028
India 
Phone  8217399902  
Fax    
Email  varunikulkarni905@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrVaruni P Kulkarni 
Designation  Second PG scholar 
Affiliation  JSS AYURVEDA MEDICAL COLLEGE, MYSURU-570028 
Address  Department of PG studies in Kaumarabhritya OPD 11 JSS Ayurveda Medical College Lalitadripuram road Mysuru

Mysore
KARNATAKA
570028
India 
Phone  8217399902  
Fax    
Email  varunikulkarni905@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrVaruni P Kulkarni 
Designation  Second PG scholar 
Affiliation  JSS AYURVEDA MEDICAL COLLEGE, MYSURU-570028 
Address  Department of PG studies in Kaumarabhritya OPD 11 JSS Ayurveda Medical College Lalitadripuram road Mysuru

Mysore
KARNATAKA
570028
India 
Phone  8217399902  
Fax    
Email  varunikulkarni905@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital Lalitadripuram road Mysuru 570028 
 
Primary Sponsor  
Name  DrVaruni P Kulkarni 
Address  # 3 6 132 near Ganesh katta Fort area Beroon quilla Raichur 
Type of Sponsor  Other [] 
 
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 
DrJyothy KB  JSS Ayurveda Medical Hospital  Department of PG studies in Kaumarabhritya OPD 11
Mysore
KARNATAKA 
7776014076

jyothybmenon@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS AYURVEDA MEDICAL COLLEGE  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: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Khadira and Asana kwatha bhavitha Triphala churna, Reference: Arogya Raksha Kalpa Druma, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: honey), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Triphala churna, Reference: Charaka samhitha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -honey), Additional Information: -
 
Inclusion Criteria  
Age From  10.00 Day(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1. Subjects from age group 10-16 years, irrespective of gender and socioeconomic status.
2. Obesity caused due to Exogenous factors like over-eating and poor physical activities.
3. Body mass index of 23kg/m2 and27kg/m2 respectively i.e. body weight between 85th -95th percentile for the selected age group.
4. Subjects having signs and symptoms of Sthoulya as explained in Ayurveda.
5. Parents ready to sign written informed consent.


 
 
ExclusionCriteria 
Details  1. Known cases of endocrine disorders like Hypothyroidism and Cushing’s syndrome.
2. Any other systemic and genetic disorders.
3. Drug induced obesity 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of the trial drug with that of standard drug on the values of Body Mass Index Weight Skin Fold Thickness Mid upper arm circumference  6 months  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the efficacy of trial & standard drugs on Health Related Quality Of Life(HRQoL) parameters  70 days 
 
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 1/ Phase 2 
Date of First Enrollment (India)   25/07/2023 
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="1"
Months="5"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Sthoulya is a condition described under Shleshma nanatmajavyadhi (1), Santarpana nimittaja vyadhi(2) and Atibrimhana nimittajavyadhi(3). It is described as Upachita shareeratvam(4) and is characterized by excess accumulation of Medas. There are many lakshana of Sthoulya(5) as mentioned in Ayurveda , of which a few symptoms that are commonly found in children are Atinidra, Alasya, Ayase Shwasa and Atikshudha.

 

 

The clinical symptomatology of Sthoulya is similar to that of Overweight and Obesity in contemporary science, which has been defined as, a body mass index of 23kg/m2 and 27kg/m2 respectively. (Indian cutoffs after 2 years of age, which is between 85th to 95thpercentile) (6) Enlargement of fat cell in its size; or an increase in number of fat cells; or both, leads to abnormal growth of adipose tissue which is known as obesity. In such condition, body fat is extensively accumulated under the skin and around certain organs such as belly, breasts, thighs (7)

 

 

According to a study in 2021, the prevalence of overweight and obesity among school children in Mysuru, Karnataka showed that there was 3.86% of obesity and 12.27% of overweight (8). A recent study conducted 2021, in school children of Mysuru, Karnataka revealed significant differences in variables such as body weight and BMI, before and after lockdown. Post lockdown the BMI increased among all the participants from 17.32 to 17.80 kg/m2 (p<0.001). The study also depicted that obesity has a proportional impact on the children’s quality of life (QOL)(9) In a recent study done in Rishikesh ,Uttarakhand, in the year 2021,it was found that 6.8% of adolescents were obese and that about 17.1% were overweight.(10) These studies give enough proof for the prevalence of overweight and obesity among children even in adolescent age group.

 

 

Some of the common complications of childhood obesity, if left unattended are Obstructive sleep apnea, Asthma, Acanthosis nigricans and Polycystic ovarian syndrome and Psychological problems like Anxiety, Low self esteem and Worsening school performance (11,12). Contemporary science has a multi disciplinary approach in the management of obesity, like lifestyle modification, regular meal timings and at least 7-8 hours of sleep at night (12).

 

 

Ayurveda also describes multi model therapy including diet, medicine and life style modifications for Sthoulya. Some of the Shamanoushadhi indicated for Sthoulya are Triphala churna, Vidanga Churna, Vidangadhya louham and Navakaguggulu. (13) Usage of Triphala and Madhu have been specifically mentioned in Sthoulya chikitsa in Charaka Samhita and Ashtanga Samgraha (14). According to the Kerala based text dealing with Kaumarabhritya viz; Arogya Raksha Kalpa Druma

,Triphala triturated in the Kwatha of Khadira and Asana, consumed for 1 month reduces Sthoulya. It has been specifically mentioned for children (15). A previous clinical study conducted in the year of 2011 have shown significant results of Khadira and Asana Kwatha Bhavitha Triphala in children


of 5-15 years with Sthoulya in comparison to the control group -Pathya.

 

Based on the above references, the present study has been planned to evaluate the efficacy of Bhavita Triphala churna in Sthoulya viz a viz childhood overweight and obesity in adolescent children.

 
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