| CTRI Number |
CTRI/2025/11/098111 [Registered on: 26/11/2025] Trial Registered Prospectively |
| Last Modified On: |
22/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of smoothie on Complete blood Count: A randomized controlled trial |
|
Scientific Title of Study
|
Combined effect of beetroot, Pomegranate, and Jaggery Smoothie on Complete blood Count: A randomized controlled 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 Jyoti Madhur |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekanand Subharti University, Meerut |
| Address |
Room no. 5,
Dept.: Naturopathy & Yoga
College: MASCHNYS,
Subharti University, Meerut, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyoti Madhur |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekanand Subharti University, Meerut |
| Address |
Room no. 5,
Dept.: Naturopathy & Yoga
College: MASCHNYS,
Subharti University, Meerut, India
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Madhur |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekanand Subharti University, Meerut |
| Address |
Room no. 5,
Dept.: Naturopathy & Yoga
College: MASCHNYS,
Subharti University, Meerut
UTTAR PRADESH
250005
India |
| Phone |
9758497123 |
| Fax |
|
| Email |
jyotimadhur05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swami Vivekanand Subharti University, Meerut, India, (Pincode- 250005) |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Madhur |
| Address |
Swami Vivekanand Subharti University, Meerut, India, (Pincode- 250005) |
| Type of Sponsor |
Other [Private University] |
|
|
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 Jyoti Madhur |
Naturopathy & Yoga Hospital |
Room no. 5,
Dept.: Naturopathy & Yoga
College: MASCHNYS,
Subharti University, Meerut, India
Meerut
UTTAR PRADESH |
9758497123
jyotimadhur05@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: D509||Iron deficiency anemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Beetroot, Pomegranate & Jaggery Smothie |
for 1 month except sundays |
| Comparator Agent |
Neutral water |
1 month except sundays |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Individuals having mild and moderate anaemia. Patients who are willing to participate. |
|
| ExclusionCriteria |
| Details |
Subjects with heavy and clotted menstrual cycle
Subjects with cardiac and pulmonary diseases, renal disorders,
hemoglobinopathies, menstrual disorders, diabetes, haemolytic anaemia.
Subjects who are already taking iron supplementation for iron deficiency
anemia.
Patients under haemoglobin medications. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve the Complete Blood Count (CBC) in anaemic patients |
at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/12/2025 |
| 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="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
|
Need for the study: Anaemia is described as a reduction in the total amount of haemoglobin or the number of erythrocytes. According to the WHO Global Database on Anaemia for 1993–2005, this covered nearly 50% of the world’s population, and the assessed occurrence of anaemia was 25%. Anaemia influences almost 1.62 billion people, including approximately 293 million preschool-aged children, 56 million pregnant women, and 468 million non-pregnant women evaluated to be anaemic, worldwide.
Primary objective: To assess the increase in Haemoglobin level (Hb) and iron level (Serum Ferritin) Secondary Objective: CBC - Mean corpuscular volume (MCV), and red cell distribution width (RDWcv)
MATERIALS & METHODS: Source of Data: This study will be conducted in the Naturopathy and Yoga OPD & IPD, Chhatrapati Shivaji Hospital in Subharti University, Meerut.
Data will be collected from the medicine department in Chhatrapati Shivaji Subharti Hospital (CSSH), Meerut and the Naturopathy and Yoga department (OPD and IPD) of Subharti University, Meerut.
Treatment will be done in Naturopathy and Yoga OPD & IPD, Subharti University, Meerut. Study design- A randomised controlled trial.
|