| CTRI Number |
CTRI/2018/06/014376 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
12/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
blood level can be increased on taking an Ayurvedic Formulation "Vidangadi Lauha" in Girls Of Age Group 10-16 Years. |
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Scientific Title of Study
|
Efficacy Of Vidangadi Lauha In The Management Of Pandu Roga (Iron Deficiency Anaemia) In Adolescent Girls: An Open Label Randomized Controlled Clinical Trial.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Monika |
| Designation |
P.G Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi.
Gautampuri, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
9711728156 |
| Fax |
|
| Email |
ayurmonika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajagopala S |
| Designation |
Associate Professor, Dept. of Kaumarabhritya, |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi.
Gautampuri, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
7600902564 |
| Fax |
|
| Email |
srajagopala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monika |
| Designation |
P.G Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, Mathura Road, New Delhi.
Gautampuri, Sarita Vihar, Mathura Road, New Delhi-110076
New Delhi
DELHI
110076
India |
| Phone |
9711728156 |
| Fax |
|
| Email |
ayurmonika@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Ayurveda, Gautampuri, Sarita Vihar,
Mathura Road, NEW DELHI - 110 076. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Gautampuri, Sarita Vihar,
Mathura Road, NEW DELHI - 110 076. |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika |
All India Institute Of Ayurveda |
Gautampuri, Sarita Vihar,
Mathura Road, NEW DELHI - 110 076. Department of Kaumarabhritya, Academic Block, Room No 212.
New Delhi
DELHI |
9711728156
ayurmonika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
Mild to moderate iron deficiency anaemia. , (1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Iron and Folic acid |
In Tablet form, Containing Iron 60 mg and Folic acid 400 microgram.
frequency- one tablet once/day
duration- 3 months |
| Intervention |
VIDANGADI LAUHA |
In syrup/Malt form
(jaggery based syrup/malt) with dose of 10 ml/day, containing vidangadi Lauha 250 mg.
frequency- 10 ml once/day
total duration- 3 months |
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Female |
| Details |
Female patients between the age group of 10-16 years.
Patients presenting clinical sign and symptoms of Pandu Roga (IDA).
Patients with mild to moderate anaemia (haemoglobin level from 11g/dl to 8g/dl).
Patients/Parents giving consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Females below 10 years and above 16 years of age.
Patients with severe anaemia (haemoglobin level <8g/dl) requiring hospitalization and
BT, patients of T.B, D.M, heart diseases, liver diseases and other chronic systemic
disorders.
Conditions like menorrhagia, piles, fissures and other haemorrhagic conditions.
Anaemia in case of defective absorption due to gastrectomy, sprue syndrome.
Any other systemic disease wherein anaemia is one among the presenting complaints. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Haemoglobin g/dl |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in signs and symptoms of Pandu Roga (IDA).
Improvement in CBC, Serum Iron, Serum Ferritin and TIBC.
Improvement in quality of life (QOL) parameters, (WHOQOL) [23]. |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/07/2018 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
RESEARCH QUESTION What is the efficacy of the oral administration of Vidangadi Lauha syrup/malt in managing Pandu Roga (IDA) in comparison with that of Iron and Folic acid in adolescent girls? HYPOTHESIS Blood haemoglobin level is improved and sign and symptoms of Pandu Roga (IDA) are reduced in adolescent girls who receive daily Vidangadi Lauha syrup/malt for a period of 3 months with the dose of 10ml OD, compared with the adolescent girls who receive Iron and Folic acid with the dose of iron-60mg and folic acid-400microgram/day for same period of time. Null hypothesis- H0: In the proposed clinical trial null hypothesis is that the efficacy of Vidanagadi Lauha is no better, on average in comparison with the Iron and Folic acid. Alternate hypothesis- H1: The alternative hypothesis is that the efficacy of Vidangadi Lauha is better in comparison with that of Iron and Folic acid. |