| CTRI Number |
CTRI/2024/04/065481 [Registered on: 09/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/08/2025 |
| 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 wheatgrass juice on lipid profile in individual with increased cholesterol level |
|
Scientific Title of Study
|
Effect of wheatgrass juice on lipid profile among hypercholesterolemic individual as an adjuvant to conventional treatment - A prospective randomized control trial |
| 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 Vivek Singh |
| Designation |
PG Student |
| Affiliation |
Maharishi Aurobindo college and hospital of naturopathy and yogic sciences |
| Address |
Department of Post Graduate Studies, Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, Meerut 250005, Uttar Pradesh, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8853021590 |
| Fax |
|
| Email |
vs416301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Aurobindo college and hospital of naturopathy and yogic sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut Uttar Pradesh India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankare Gowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo college and hospital of naturopathy and yogic sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram Meerut Uttar Pradesh India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9448300348 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University and Camp organised by Swami Vivekanand Subharti University
NH 58 Delhi Haridwar Bypass Road, Meerut 250005, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Singh |
| Address |
Department of Post Graduate Studies, Subharti College and Hospital of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, Meerut 250005, Uttar Pradesh, India |
| 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 Vivek |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Department of Post Graduate Studies, Subharti College and Hospital of Naturopathy and Yogic Sciences,Swami Vivekanand Subharti University Subhartipuram NH 58 Delhi Haridwar Bypass Road ,Meerut 250005, Uttar Pradesh , India
Meerut
UTTAR PRADESH |
8853021590
vs416301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E780||Pure hypercholesterolemia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional medicine |
Oral medication |
| Intervention |
Wheatgrass juice |
A fine paste of 50 grams of fresh wheatgrass and 100 ml of water combine to make wheatgrass juice and taste and palatability were improved by adding 2 or 3 drops of lemon juice for 21 days once in the morning empty stomach |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to join the study |
|
| ExclusionCriteria |
| Details |
Any types of wheat Allergy.
Subject who have gone through bypass grafting and angioplasty.
Subjects have prior stroke.
Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total cholesterol levels |
Before intervention and after 21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LDL , VLDL , HDL |
Before intervention & after 21 days |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
10/03/2025 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Prospective Randomised control trial study aims to see the effect of wheat grass juice on lipid profile among hypercholesterolemic patients . This study is allocated in two groups , the intervention group will take 50 gram of wheat grass with 100 ml of water and conventional treatment for 21 days while control group will take conventional treatment only. Data will examined before the intervention and after the intervention. Wheat grass having tannin, saponins, sterols which helps in decrease the level of cholesterol. |