| CTRI Number |
CTRI/2024/08/072555 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Navayasa Lauha in the Management of Iron Deficiency Anaemia in School Going Children |
|
Scientific Title of Study
|
Clinical Evaluation of Navayasa Lauha in the Management of Iron Deficiency Anaemia in School Going Children – A Single Arm Interventional 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.SURENDRA SINGH GURJAR |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no: 222, KAUMARBHRITYA-BALROG,DEPARTMENT
NIA JAIPUR
Jorawar singh Gate, Old amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
09414815152 |
| Fax |
|
| Email |
Dr.surendragurjar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brahm Dutt Sharma |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of kaumarbhritya National Institute of Ayurveda, Jorawar singh Gate, Old amer road, Jaipur
Jorawar singh Gate, Old amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887859095 |
| Fax |
|
| Email |
dr.bdsharma@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.SURENDRA SINGH GURJAR |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No: 222, KAUMARBHRITYA-BALROG DEPARTMENT
NIA JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
09414815152 |
| Fax |
|
| Email |
Dr.surendragurjar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director National Institute of Ayurveda, Jaipur, 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar Singh Gate, Old Amer Road, Jaipur, Rajasthan |
| Type of Sponsor |
Government medical college |
|
|
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 Surendra Singh Gurjar |
National Institute of Ayurveda |
OPD NO-5, BALROG OPD, National Institute of Ayurveda
Jaipur
RAJASTHAN |
09414815152
Dr.surendragurjar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navayasa Lauha, Reference: AFI PArt 2 , First English edition, 17/2, page 303, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 125(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Madhu-Ghrita), Additional Information: 6-9 years - 1/2 125mg tab (12 hourly)
10-12 years - 1 125mg tab (12 hourly) |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Children aged between 06 to 12 years of either sex.
2. Children with Iron deficiency anaemia.
3. Children with Haemoglobin% less than 11.9 gm/dl and more than 7.0 gm/dl. (Mild and moderate anaemia)
|
|
| ExclusionCriteria |
| Details |
1. Children with severe anaemia (Hb more than 7.0 gm/dl)
2. Children with major systemic illness requiring hospitalization.
3. Children with co morbidities like TB, UTI, and Bleeding disorders.
4. Children with any congenital anomalies or birth defects or genetic disorder.
5. Children with evidence of malignancy.
6. Children with concurrent serious hepatic dysfunction (defined as AST and or ALT more than 3time of the upper normal limit) or renal dysfunction (define as S. Creatinine more than 1.2mg/dl)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Haemoglobin, RBC Count, PCV, MCV, MCH, MCHC, PBS, Serum Iron, Serum Ferritin and TIBC |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in quality of life in children with Iron deficiency anaemia (Pandu) |
2 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)
|
15/10/2024 |
| 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="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
|
Infants,
preschool children, and adolescents are at greatest risk of developing iron
deficiency and its resultant anaemia, which later affects their physical as
well as mental development. The effect of anaemia on child development are
serious: poor cognitive development, decreased future learning, and school
achievement, decreased resistance to illness and disease and eventually reduced
wages and quality of life. Numerous studies have shown that moderate anaemia with haemoglobin less than
10g/dl is associated with depressed mental, social, cognitive and motor
development in children which may not be reversible.
Nutritional
deficiency is considered to be the main culprit in Iron Deficiency Anaemia. The
management programmes are exclusively aimed on providing iron and other
nutrients. On the other hand, various factors that hamper the digestion and
metabolism are postulated as the key etiological factors for Pandu.
Hence
there is always a search for better remedies which will not cause adverse effects
like gastrointestinal disturbances, metallic taste and can be well accepted by
children. There are many formulations listed in different Ayurveda texts for
the management of Pandu. Among
them Navayas Lauha which is explained by Acharya Charaka in Panduroga
Chikitsa is the one which contains iron and other components which can
correct the metabolism by which absorption and bioavailability of iron as well
as other nutrients can be enhanced. Studies conducted earlier have shown that
correction of metabolism is an essential part in the management of nutritional
deficiency conditions.
Thus,
this study is planned to clinical evaluation of Navayasa Lauha in the
management of Iron Deficiency Anaemia in school going children-single
arm prospective interventional trial. |