| CTRI Number |
CTRI/2024/07/071187 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
23/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Tara Mandura Guda in Obesity |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Trial To Evaluate The Effect Of Tara Mandura Guda And Navaka Guggulu In The Management Of Sthoulya w.s.r To 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 |
Dr Vidya Maishale |
| Designation |
Pg Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
Sdm trusts
Ayurvedic medical college danigond post graduation centre padma ayurvedic hospital and research centre
Dr siddhant nagar
Terdal 587315
Bangalore
KARNATAKA
587315
India |
| Phone |
9148918426 |
| Fax |
|
| Email |
vidmaishale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukumar Nandigoudar |
| Designation |
Professor |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre
Dr Siddhant Nagar
Terdal 587315
Bagalkot
KARNATAKA
587315
India |
| Phone |
9986125625 |
| Fax |
|
| Email |
vaidyasukumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Maishale |
| Designation |
Pg Scholar |
| Affiliation |
Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre |
| Address |
SDM Trusts
Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar
Terdal 587315
Bagalkot
KARNATAKA
587315
India |
| Phone |
9148918426 |
| Fax |
|
| Email |
vidmaishale@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Post Graduation And Research Terdal |
|
|
Primary Sponsor
|
| Name |
Dr Vidya Maishale |
| Address |
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka |
| Type of Sponsor |
Other [SELF] |
|
|
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 Vidya Maishale |
Padma Ayurvedic Hospital And Research Centre |
OPD Department Of Kayachikitsa Ground Floor Padma Ayurvedic Hospital And Research Centre Terdal 587315
Bagalkot
KARNATAKA
Bagalkot
KARNATAKA |
9148918426
vidmaishale@gmmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College and Padma Ayurvedic Hospital INSITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tara Mandura Guda, Reference: Bhaishajya Ratnavali Shula rogadhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna Jala), Additional Information: Bhaishajya kala - Pragh-Madhya-Adho Bhakta | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navaka Guggulu, Reference: Bhaishajya Ratnavali Medhoroga Adhikara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having classical signs and symptoms of
Sthoulya.
2. Patient with BMI above 25 and below 40.
3. Both fresh and treated cases, who are not on
medication for obesity atleast for 1 month.
4. Subjects willing to sign consent.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and Lactating women’s.
2. Diagnosed cases of PCOD, Hypothyroidism,
Diabetes mellitus and Hypertension who are on
medications.
3. Any other conditions where researcher may feel
it may intervein the study.
4. Patients under on going concomitant medications
which may intervein the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial drug on improvement in classical symptoms of Sthoulya (Obesity) |
15day, 30day, 60day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of the trial drug and adverse drug reaction and aggravation in the symptoms of Sthoulya (Obesity) |
15day, 30day, 60day |
|
|
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)
|
09/08/2024 |
| 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 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
|
Obesity
is the prime factor in initiating the diseases like dyslipidemia, DM, HTN, CAD
and menstrual irregularities due to drastic change in lifestyle and dietary
habit. According to WHO a BMI over 25 is overweight and over 30 as obese, 4
million people die each year as a result of obesity, WHO has undertaken obesity in 10 selected risks
to the health on world heath report 2002. India is 3rd most obese
country in the world. By 2030 one in five women and one in seven men will have
obesity.
Classical
ayurveda texts have explained Asta-Nindita Purushas among which Sthoulya is one
and a Santarpanajanya Vyadhi which can be compared to obesity in contemporary
science having cardinal features like, Chala-Sphik-Udara-Stana, Sweda Adhikya,
Daurbalya etc. Hence attempt is made to evaluate the effect of Tara Mandura
Guda and Navaka Guggulu in the management of Sthoulya.
Tara
Mandura Guda is mentioned in Bhaishyajya ratnavali 30th chapter.
It
is a Randomized Controlled Clinical Trial 40 patients of Sthoulya will be
selected incidentally and randomly assigned into two groups; Group ‘A’ and ‘B’
by software generated chart.
Group
Aand Group B patients will be given Tara Mandura Guda and Navaka Guggulu
respectively subjects will be assessed on the basis of BMI, weight,
Anthropometry, Skin fold thickness with classical signs and symptoms.
Total
study duration will be 60 days containing 4 visits (0th day, 15th
day, 30th day, 60th day) which includes administration of
trial drug for 30 days and post medicine follow up on 60th day.
After study, data will be collected from Case report Form (CRF) and
statistically analysed by using appropriate parametric and non-parametric tests
and results will be obtained.
On
the basis of results, conclusion will be drawn.
|