| CTRI Number |
CTRI/2024/02/062650 [Registered on: 14/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Drumstick leaf powder consumption on blood sugar, blood pressure and fat levels in patients of metabolic syndrome with elevated blood sugar, blood pressure and fat levels: A randomized controlled trail. |
|
Scientific Title of Study
|
Effect of Moringa Leaf powder on Glycaemic profile, Lipid profile, Blood pressure levels in individuals with Metabolic Syndrome - A Randomised Control Trail |
| 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 Manjunath R |
| Designation |
PG Scholar |
| Affiliation |
shri dharmasthala manjunatheshwara college of naturopathy and yogic scienece |
| Address |
shri dharmasthala manjunatheshwara college of naturopathy and yogic sciences, department of diet and nutrition, ground floor, room no 7, ujire, belthangady taluk, Dakshina Kannada.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9740819483 |
| Fax |
|
| Email |
manjunathr7797@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Shetty |
| Designation |
Principal |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences. |
| Address |
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences, Ujire, Belthangady taluk, Dakshina Kannada.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9448252696 |
| Fax |
|
| Email |
drprashanth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjunath R |
| Designation |
PG Scholar |
| Affiliation |
shri dharmasthala manjunatheshwara college of naturopathy and yogic scienece |
| Address |
shri dharmasthala manjunatheshwara college of naturopathy and yogic sciences, department of diet and nutrition, ground floor, room no 7, ujire, belthangady taluk, Dakshina Kannada.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9740819483 |
| Fax |
|
| Email |
manjunathr7797@gmail.com |
|
|
Source of Monetary or Material Support
|
| shri dharmasthala manjunatheshwara college of naturopathy and yogic science |
|
|
Primary Sponsor
|
| Name |
Dr Manjunath R |
| Address |
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences, Department of Diet and Nutrition, Ground floor, Room no 7, Ujire, Belthangady taluk, Dakshina Kannada. |
| 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 Manjunath |
Sri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital |
Shantivana, Department of Diet and Nutrition, ground floor, room no 7, Ujire, Belthangady taluk, Dakshina Kannada, Karnataka.
Dakshina Kannada
KARNATAKA |
09740819483
manjunathr7797@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri dharmasthala manjunatheshwara college of naturopathy and yogic sciences, ujire, dakshina kannada |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cold water |
daily intake of 250ml of cold water without adding the moringa oleifera leaf powder for 8 weeks. |
| Intervention |
moringa leaf powder |
daily intake of 20g of moringa oleifera leaf powder in 250ml in cold water for 8weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Diagnosis of metabolic syndrome is based on NCEP ATP III criteria for Asian population.
2) willing participants |
|
| ExclusionCriteria |
| Details |
1) Pregnant women
2) Chronic kidney disease
3) Alcohol consumption
4) Steven Johnson syndrome
5) Malabsorption syndrome
6) Active infectious disease during screening |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| glycemic profile, lipid profile, blood pressure |
base line and after 8 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| quality of life |
base line and after 8 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/02/2024 |
| 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 Applicable |
| 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
|
effect of moringa leaf powder on glycemic profile, lipid profile, blood pressure levels in patients with metabolic syndrome
groping- 2 groups
group 1 (intervention group) - 20g moringa leaf powder in 250ml of cold water group 2 (control group) - 250ml 0f cold water
methods- the subjects were recruited as per inclusion and exclusion criteria. signed informed consent form will be obtained from every participant after the appraisal about the purpose of the study. selected subject will be randomly allocated into 2 groups by chit randomization method.
pre assessment prior to intervention and post assessment will be after 8 weeks of intervention using the outcome variables. the collected data will be tabulated and analyzed using appropriate statistical method.
|