| CTRI Number |
CTRI/2025/03/083555 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| 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 taking flaxseed on blood pressure and lipid level in high blood pressure subjects from manipuri community |
|
Scientific Title of Study
|
Effect of flaxseed consumption on blood pressure and lipid profile in hypertensive individuals from Manipuri community-Randomized control study |
| 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 Roshni Moirangthem |
| Designation |
PG Student |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy and Yoga Sciences, Ujire |
| Address |
Department Of Nutrition and Dietetics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science Ujire, Belthangady, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8729923305 |
| Fax |
|
| Email |
moirangthemroshni0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roshni Moirangthem |
| Designation |
PG Student |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy and Yoga Sciences, Ujire |
| Address |
Department Of Nutrition and Dietetics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science Ujire, Belthangady, Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8729923305 |
| Fax |
|
| Email |
moirangthemroshni0@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth Shetty |
| Designation |
Principal And Dean Division Of Nutrition And Dietetitcs |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College Of Naturopathy and Yoga Sciences, Ujire |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Science Ujire, Belthangady, Dakshina Kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9448252696 |
| Fax |
|
| Email |
drprashanth9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Individual with Hypertension from Manipur admitted at Sri Dharmasthala Manjunatheshwara nature cure hospital, shanthivana, dharmasthala |
|
|
Primary Sponsor
|
| Name |
Dr Roshni Moirangthem |
| Address |
SDM College of Naturopathy and Yogic Science Ujire, Belthangady, Dakshina Kannada,574240 |
| 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 Roshni Moirangthem |
Sri Dharmasthala Manjunatheshwara nature cure hospital, shanthivana |
Sri Dharmasthala Manjunatheshwara nature cure hospital, shanthivana, dharmasthala, dakshina kannada 574240
Dakshina Kannada
KARNATAKA |
8729923305
moirangthemroshni0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Naturopathy And Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anti-Hypertensive drugs |
subjects will continue their regular anti-hypertensive medication without any other intervention |
| Intervention |
Flaxseed |
given 15gms of grounded Flaxseed powder mixed with water before meals twice a day with regular medications for 3 months |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. age from 35 to 70
2. both the genders
3. subjects with systolic blood pressure more than or equal to 130 mmHg and diastolic blood pressure more than 80 mmHg with anti hypertensive drugs
4. hypertensive subjects who are willing for the study
|
|
| ExclusionCriteria |
| Details |
1. Pregnant women
2. Uncontrolled Hypertension
3. Mental Disorders
4. Sensitivity to flax seed
5. Consuming omega 3 or herbal medicine
6. Renal diseases
7. Impaired blood sugar
8. History of obstructive and inflammatory bowel disease, celiac disease, gastric ulcers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure - systolic blood pressure, diastolic blood pressure, mean arterial pressure and pulse pressure |
pre intervention before conducting the soon after recruitment of subjects to the respective groups
post-intervention after completing the 90 days of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Lipid profile
2. Quality of life Questionnaire |
pre intervention before conducting the soon after recruitment of subjects to the respective groups
post-intervention after completing the 90 days of intervention |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
20/04/2025 |
| 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="0"
Months="4"
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
|
As flaxseeds is currently readily available and provide a safe, cost effective functional food to combat hypertension, no study was found to observed the impact of flaxseed on blood pressure and total lipid profile in Manipur. Hence, this study aims to investigate the effect of flaxseed on blood pressure and total lipid profile in hypertensive individuals from Manipuri community. |