CTRI Number |
CTRI/2019/09/021087 [Registered on: 06/09/2019] Trial Registered Prospectively |
Last Modified On: |
05/09/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
Anti obese potential of Triphala Madhupaka |
Scientific Title of Study
|
A clinical evaluation of Anti obesity(sthoulyahara) action of Triphala Madhupaka |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Madan Kumar S D |
Designation |
POST GRADUATE |
Affiliation |
|
Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan
Hassan KARNATAKA 573201 India |
Phone |
9743620410 |
Fax |
|
Email |
madangowda1993@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shivakumar |
Designation |
Doctor |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Associate professor, Department of swasthavritha, OPD 7, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan
Hassan KARNATAKA 573201 India |
Phone |
09886259437 |
Fax |
|
Email |
drshiva.k@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Madan Kumar S D |
Designation |
Doctor |
Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan
Hassan KARNATAKA 573201 India |
Phone |
9743620410 |
Fax |
|
Email |
madangowda1993@gmail.com |
|
Source of Monetary or Material Support
|
Dr. Madan Kumar S D, Post Graduate Scholar, Department of Swasthavritha, Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital, Hassan- 573201
Karnataka |
|
Primary Sponsor
|
Name |
Dr Madan Kumar S D |
Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hassan |
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 |
Dr Madan Kumar S D |
Sri Dharmasthala Manjunatheshwara |
OPD 7, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, BM road, Hasan Hassan KARNATAKA |
9743620410
madangowda1993@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
nil |
nil |
Intervention |
Triphala Madhupaka |
6gms of Triphala Madhupaka is given twice a day orally before food for 30 days |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
Ready to give informed return consent |
|
ExclusionCriteria |
Details |
Obesity due to secondary causes
PCOD
Hypothyroidism
History of steroidal or hormonal therapy, oral contraception
Patients suffering from chronic metabolic disorders
Subjects with mental illness
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
All the patients who fit in inclusion criteria will be given treatment with Triphala Madhupaka 6gm twice daily before food |
will be assessing on baseline treatment, 15th day and on 30th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of life |
will be assessing on baseline treatment, 15th day and on 30th 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
|
Phase 2 |
Date of First Enrollment (India)
|
11/09/2019 |
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="5" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
none yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Ayurveda recommended intake of food articles that which maintain the health and prevent un manifested diseases. An ancient balanced diet consists of food articles which are listed in Nithyasevaniyaahara. Madhu is one among the nithyasevaniyaahara. It has medohara and lakshanas effect when it is one year old. Obesityis a medical condition in which excess body fat accumulates to an extent that it may have a negative effect on health. Obesity increases the likely hood of various diseases, particularly heart disease, type 2 diabetes, obstructive sleep apnoea, certain types of cancer, and osteoarthritis. Obesity is most commonly caused by a combination of excessive food intake, lack of physical activity, and genetic susceptibility.Worldwide obesity has nearly tripled since 1975.In 2016, more than 1.9 billion adults, 18 years and older, were overweight Of these over 650 million were obese.39% of adults aged 18 years and over were overweight in 2016, and 13% were obese. Most of the world’s population in countries where overweight and obesity kills more people than underweight. Ayurveda emphasizes the use of Purana Madhu as a nutritional therapy in Sthoulya. Triphala is another drug used in combination for the same. Triphala Madhupaka is experimentally analysed for its, in-vitro anti-obese action and found to be safe for oral consumption. But it is not clinically proven hence, in this study Triphala Madhupaka will be used to assess its anti-obese action.. |