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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Drug | Classical | | (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. |