| CTRI Number |
CTRI/2025/08/093307 [Registered on: 20/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized Controlled Trial of Ragi laddu as a Dietary Supplement in Iron Deficiency Anemia among Adolescents. |
|
Scientific Title of Study
|
A Randomized Controlled Trial of Ragi Modak (Finger Millet) as a Dietary
Supplement in Iron Deficiency Anemia among Adolescents. |
| 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 Varsha Sagar Karyappa |
| Designation |
BAMS PG scholar |
| Affiliation |
Government Ayurved college and Hospital, Nagpur. |
| Address |
Government Ayurved
college and Hospital Sakkardhara Chowk Raje Raghuji Nagar
Nagpur440024 Maharashtra India Sakkardhara Chowk Raje
Raghuji Nagar, Nagpur440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7743829868 |
| Fax |
|
| Email |
varshakaryappa1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidya Wasnik Thatere |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved college and Hospital Nagpur. |
| Address |
Government Ayurved
college and Hospital Sakkardhara Chowk Raje Raghuji Nagar
Nagpur440024 Maharashtra India Sakkardhara Chowk Raje
Raghuji Nagar, Nagpur440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9423723503 |
| Fax |
|
| Email |
vidya.wasnik@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Sagar Karyappa |
| Designation |
BAMS PG scholar |
| Affiliation |
Government Ayurved college and Hospital Nagpur |
| Address |
Government Ayurved
college and Hospital Sakkardhara Chowk Raje Raghuji Nagar
Nagpur440024 Maharashtra India Sakkardhara Chowk Raje
Raghuji Nagar, Nagpur440024 Maharashtra India
Nagpur
MAHARASHTRA
440024
India |
| Phone |
7743829868 |
| Fax |
|
| Email |
varshakaryappa1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD patients of Government Ayurved College and Hospital Nagpur, Shakkardhara Chowk, Nagpur, Maharashtra,India
440024 |
|
|
Primary Sponsor
|
| Name |
Dr.Varsha Sagar Karyappa |
| Address |
Government Ayurved college and Hospital, Sakkardhara Chowk,Nagpur |
| Type of Sponsor |
Other [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 |
| DrVarsha Sagar Karyappa |
Government Ayurved college and Hospital, Nagpur and its periphery |
OPD NUMBER 6,
Swastharakshan
Department,
Government Ayurved
College and Hospital,
sakkardhara chowk,
raje Raghuji Nagar,
Nagpur, Maharashtra.
Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
7743829868
varshakaryappa1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurved college Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E638||Other specified nutritional deficiencies. Ayurveda Condition: RASAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Ragi Modak 2 BD with Iron 60mg and Folic acid 500 mcg 1 BD for 60 days, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Iron and Folic acid supplements | Iron 60 mg and Folic acid 500 mcg one capsule twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals between the age group of 10 to 18 years irrespective of sex, religion,
education, socio economic status.
2. The subject having Hb more than 8gm per dl and less than 11.4 gm per dl.
3. Parents or Guardian willing to give informed consent to participate in study. |
|
| ExclusionCriteria |
| Details |
1. Subjects having any systemic and congenital diseases.
2. Subjects suffering from Anemia due to other systemic disorders or infections.
3. Having any type of bleeding disorders.
4. Subjects not willing for Trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Ragi Modak on Iron Deficiency Anemia.
2. To compare the clinical efficacy of Ragi Modak with that of Iron & Folic acid
Supplement.
3. To study the effect of Ragi Modak on Haematological Parameters viz Serum Iron, Hb, MCV, MCH, MCHC. |
30,60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the effect of Ragi modak on sign & symptoms of iron deficiency
anemia (Pandu) & Calcium deficiency (Asthikshaya)
2. To Study & collect literature regarding Ragi (Finger Millet) from Ayurvedic
classical & Modern texts
3.To review the literature regarding Pandu & Anemia from Ayurvedic classical
& Modern texts. |
30, 60 days |
|
|
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 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="6"
Days="5" |
|
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
|
Title A Randomized Controlled Trial of Ragi Modak (Finger Millet) as a Dietary Supplement in Iron Deficiency Anemia among Adolescents. Aim To study the effect of ragi modak (Finger Millet)as a dietary supplement in iron deficiency anemia among Adolescents. Objectives Primary Objectives To study the effect of Ragi Modak on Iron Deficiency Anemia. To compare the clinical efficacy of Ragi Modak with that of Iron & Folic acid Supplement Secondary Objectives To study the effect of Ragi modak on sign and symptoms of iron deficiency anemia (Pandu) and Calcium deficiency (Asthikshaya) To Study and collect literature regarding Ragi (Finger Millet) from Ayurvedic classical & Modern texts To review the literature regarding Pandu & Anemia from Ayurvedic classical & Modern texts Methodology study design Study design An open label, Randomized Controlled Trial
Screening of the School going Adolescents will be done on the basis of Inclusion and exclusion criteria
76 subjects will be selected for the study
Informed consent from their Parents or Guardian will be taken
They will be divided into two groups randomly by computerised random sampling method
Group A Trial group 38 Individuals will be given Elemental iron 60 mg plus 500mcg folic acid 2BD plus 2BD Ragi Modak for 60 days and group B will be given Elemental iron 60 mg plus 500 mcg folic acid 2BD
Then Assessment will be done by Objective on D-0 ,D-60 and Subjective Parameters On Day 0 Day 30 and Day 60 before and after study
Statistical analysis with appropriate test and interpretation will be done
Observation and Result
Discussion
Conclusion
a Inclusion criteria 1. Individuals between the age group of 10 to 18 years irrespective of sex, religion, education, socio economic status. 2. The subject having Hb greater than 8gm per dl less than11.4 gm per dl. 3. Parents or Guardian willing to give informed consent to participate in study.
b. Exclusion criteria: 1. Subjects having any systemic and congenital diseases. 2. Subjects suffering from Anemia due to other systemic disorders or infections. 3. Having any type of bleeding disorders. 4. Subjects not willing for Trial.
|