| CTRI Number |
CTRI/2021/04/032938 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
16/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Tea] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An attempt in cases of overweight with a simple preparation of tea |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF TAMALA TEA AND GREEN TEA IN OVER WEIGHT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shaily Agarwal |
| Designation |
Doctor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
DEPARTMENT OF PG STUDIES IN SWASTHAVRITTA,
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH,
BANGALORE.
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9986527310 |
| Fax |
|
| Email |
shaily04.agarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudresh S |
| Designation |
Doctor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Associate Professor
Department of PG Studies in Swasthavritta
Sri Sri College of Ayurvedic Science and Research
Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
8123847731 |
| Fax |
|
| Email |
dr.rudresh86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shaily Agarwal |
| Designation |
Doctor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Department of PG Studies in Swasthavritta
Sri Sri College of Ayurvedic Science and Research
Bangalore
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9986527310 |
| Fax |
|
| Email |
shaily04.agarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Samhitas , contemporary modern texts, reputed journals, research articles,web sources and related work from different universities |
|
|
Primary Sponsor
|
| Name |
Dr Shaily Agarwal |
| Address |
Department of PG Studies in Swasthavritta
Sri Sri College of Ayurvedic Science and Research
Bangalore |
| Type of Sponsor |
Private 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 Shaily Agarwal |
Sri Sri College of Ayurvedic Science and Research Hospital |
Department of PG Studies in Swasthavritta
Sri Sri College of Ayurvedic Science and Research
Bangalore
Bangalore
KARNATAKA |
9986527310
shaily04.agarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E65-E68||Overweight, obesity and other hyperalimentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Green Tea |
Green Tea available in the market proved to be good for weight loss
Dose-60ml,6times/day
Route of Administration-Oral
Time of study-21 days
|
| Intervention |
Tamala Tea |
Tamaladi Tea, consists of basic ingredients available in every kitchen which is cost-effective and easily available like Tamala(cinnamon),Methi seeds,Coriander seeds and jeera seeds which is taken in equal quantity and made into powder form and made into tea by adding 2gms in hot water at once
Dose-60ml,6times/day
Route of Administration-Oral
Time of Study-21 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed over-weight will be included with BMI in between 25 to 29.9kg/m2
2.Subjects of age group between 21 to 45 years will be included irrespective of their gender, religion and socio-economic status |
|
| ExclusionCriteria |
| Details |
1.Obese subjects above BMI 30
2.Over-weight due to systemic diseases
3.Subjects taking drugs like NSAIDS, anti-histamines, oral contraceptives, sulphonamides etc.,
4.Lactating and pregnant women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-BMI and Anthropometry measurement will be evaluated(Assessment Criteria)
1.To Evaluate the effect of Tamaladi Tea in Over-weight
2.To re-evaluate the effect of Green Tea in over-weight
3.To Compare the efficacy of Tamaladi Tea and Green Tea in over-weight
|
10thday,21st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Inch loss |
10th day,21st day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/05/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shaily04.agarwal@gmail.com].
- For how long will this data be available start date provided 15-01-2022 and end date provided 15-03-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Over-weight is defined as a BMI between 25 and 29.9 kg/m2 and as abnormal or excessive fat accumulation that may impair health. The World Health Organization (WHO) has declared over-weight as one of the top 10 health risks in the world .In 2016 ,more than 1.9 billion adults ,18 years and older were over-weight .Of these over 650 million were obese. Over-weight is caused due to poor and improper food habits, chronic imbalance between intake and actual energy needs of the body and physical inactivity. Over-weight is considered as an intermediate risk factor for major chronic diseases including Obesity, Diabetes ,Heart disease, Stroke, Cancer and Chronic respiratory disease. |