| CTRI Number |
CTRI/2023/03/050756 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
15/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
clinical trial of Yashtimadhu Churna in Iron deficiency Anaemia |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Yastimadhu Churna in Pandu w.s.r. to Iron deficiency Anaemia in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gauri Vasant Devkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College Kodoli |
| Address |
OPD No 7 Kaumarbhritya OPD Ground Floor Yashwant Ayurved Hospital Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7776068323 |
| Fax |
|
| Email |
gauri.devkar01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parvatkumar Dash |
| Designation |
Professor and HOD |
| Affiliation |
Yashwant Ayurved College Kodoli |
| Address |
OPD No 7 Kaumarbhritya OPD Ground Floor Yashwant Ayurved Hospital Kodoli
Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9423277590 |
| Fax |
|
| Email |
drpkdash25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gauri Vasant Devkar |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurved College Kodoli |
| Address |
OPD No 7 Kaumarbhritya OPD Ground Floor Yashwant Ayurved Hospital Kodoli
Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7776068323 |
| Fax |
|
| Email |
gauri.devkar01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurved College Kodoli |
|
|
Primary Sponsor
|
| Name |
Gauri Vasant Devkar |
| Address |
OPD No 7 Kaumarbhritya OPD Ground Floor Yashwant Ayurved Hospital Kodoli |
| 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 |
| Gauri Vasant Devkar |
Yashwant Ayurved College PG Training Centre Kodoli |
OPD No 7 Kaumarbhritya OPD Ground Floor Yashwant Ayurved Hospital Kodoli
Kolhapur
MAHARASHTRA |
7776068323
gauri.devkar01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Churna, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous sulphate | 3-6mg/kg/day for 90 Days |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient having haemoglobin percentage in between the range of 8-10gm%.
2)Patient suffering from Pandu in between the age of 6 to 15 years.
3)Patient showing signs and symptoms of Pandu as mentioned in Charaka Samhita.
4)Patient irrespective of sex, religion, socioeconomic status.
|
|
| ExclusionCriteria |
| Details |
1)Patient having haemoglobin percentage less than 8gm%.
2)Patient below age group 6 years and above 15 years.
3)Patient suffering from haemorrhagic disorders like haemophilia, vit K deficiency etc.
4)Patient with hereditary disorders like Thalassemia, Sideroblastic anaemia, Sickle cell anaemia.
5)Patient suffering from other forms of anaemia like Aplastic anaemia, Megaloblastic anaemia etc.
6)Children with evidence of Malignancy.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease the symptoms of Pandu like Pallor Fatigue and Anorexia w.s.r. to Iron deficiency anaemia on assessment criteria like hb% |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) literature review of iron deficiency anaemia
2)clinical trial of yashtimadhu churna in Pandu
3)To assess improvement by parameters hb% at 30th day 60th day and 90th day
4)To compare the results with that of control group of ferrous sulfate
4)To achieve outcime in 90 days |
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Iron deficiency anemia is most common disease of childhood in developing countries leading to increasing morbidity affecting physical and mental health of children This is Randomized Open Controlled Clinical Study to evaluate the efficacy of Yastimadhu Churna in Pandu w.s.r. to Iron Deficiency Anaemia in children. This study will be carried out in OPD of Kaumarbhritya Department of Yashwant Ayurved College Kodoli |