| CTRI Number |
CTRI/2026/02/104657 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
21/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Black Raisins in improving Anaemia among Teenagers |
|
Scientific Title of Study
|
Evaluating the Potential Effect of Black Raisins on Iron Deficiency Anemia among Adolescents: A 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 K Venkateswari |
| Designation |
Assistant medical officer and Lecturer |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9952064809 |
| Fax |
|
| Email |
saieswari18@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M P Ramesh |
| Designation |
Assistant Medical Officer and Lecturer |
| Affiliation |
International Institute of Yoga And Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9787899899 |
| Fax |
|
| Email |
dr.rameshbnys@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr M P Ramesh |
| Designation |
Assistant Medical Officer and Lecturer |
| Affiliation |
International Institute of Yoga And Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu
TAMIL NADU 603001 India |
| Phone |
9787899899 |
| Fax |
|
| Email |
dr.rameshbnys@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr K Venkateswari |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamilnadu - 603001 |
| 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 K Venkateswari |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184/4, Department of Anatomy, Faculty block - Ground floor, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu-603001 Kancheepuram TAMIL NADU |
9952064809
saieswari18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Institutional ethical committee |
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 |
| Comparator Agent |
control group |
Participants will receive no intervention |
| Intervention |
Soaked Black Raisin Intake |
Participants will be instructed to consume the specified quantity of soaked black raisins along with 200 ml of drinking water, 15 minutes before breakfast, lunch, and dinner. The intervention will be given for 9 days per month for a duration of 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
Patients who are willing to give their consent.
|
|
| ExclusionCriteria |
| Details |
1)Anaemia other than iron deficiency anaemia
2) girls during pregnancy and lactation
3) Girls who have undergone recent surgery
4) Girls who take anticholinergic and antibiotics
5) girls who are not willing
6) Anaemic girls who participate in other studies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in haemoglobin concentration |
Baseline and at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in heart rate variability parameters |
Baseline and at the end of 3 months |
| Quality of Life Scores |
Baseline and at the end of 3 months |
|
|
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)
|
20/03/2026 |
| 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="6" Days="1" |
|
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
|
The primary purpose of this study is to assess the effect of dietary intake of soaked black raisins on haemoglobin levels among anaemic adolescent girls. The study also aims to evaluate associated changes in heart rate variability and quality of life following the intervention. Participants will be randomly allocated to a study group receiving soaked black raisins and a control group receiving no intervention for a period of three months. It is hypothesised that regular dietary intake of soaked black raisins will lead to a significant improvement in haemoglobin levels, along with favourable changes in heart rate variability and quality of life, when compared to no intervention. |