| CTRI Number |
CTRI/2024/10/074839 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
01/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare the efficacy of oral administration of dashamool syrup with iron syrup in anemia in children |
|
Scientific Title of Study
|
Randomized controlled clinical trial to compare the efficacy of oral administration of dashamool syrup with iron syrup in panduroga (anemia) in children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adesh Charandaspant Raut |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
1st floor, Kaumarbhritya department, Tilak Ayurved Mahavidyalaya, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9970421362 |
| Fax |
|
| Email |
adesh.raut97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikas B Jaybhay |
| Designation |
HOD Kaumarbhritya Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
1st floor, Kaumarbhritya department, Tilak Ayurved Mahavidyalaya, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
8888587158 |
| Fax |
|
| Email |
vikasjaybhay110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Adesh Charandaspant Raut |
| Designation |
MD Scholar Kaumarbhritya |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
1st floor, Kaumarbhritya department, Tilak Ayurved Mahavidyalaya, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9970421362 |
| Fax |
|
| Email |
adesh.raut97@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011,Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Kaumarbhritya 1st floor 583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private 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 |
| Adesh Charandaspant Raut |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
1st floor, Kaumarbhritya department, Tilak Ayurved Mahavidyalaya, Rastapeth, 583/2, Pune.
Pune
MAHARASHTRA |
09970421362
adesh.raut97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
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: Dashamoola, Reference: Yogratnakar Pandurog Chikitsa, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Iron Syrup | Iron syrup provides a source of iron.
Iron is of tremendous value to the human body. It assists in the formation of red blood cells and is a transporter of oxygen to every cell, providing us with the necessary burst of energy we all need to help us through our daily tasks. Iron also assists the memory and the ability to concentrate, and can improve the state of healthy activity and mood. In addition, Iron helps build resistance to infection, stress and disease. |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children presenting with classical signs and symptoms of Panduroga (Anemia).
Children with hemoglobin percentage between 8 to13 g/dl. |
|
| ExclusionCriteria |
| Details |
Children with severe known case of anemia due to systemic disorders, Hemorrhagic diseases like Hemophilia, Vitamin k deficiency and Anemia due to other than nutritionaldeficiency.
Known case of hereditary Anemia.
Children with known case of concurrent serious hepatic dysfunction and renal
dysfunction and uncontrolled Pulmonary Dysfunction.
H/O sensitive to any of the trial drugs.
Blood Hemoglobin level less than 8 g/dl.
Anemia with any associated severe complications. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in pandutwa, duration og play, aruchi, shwasa, hridyaspandan, shotha, constipation. |
15 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in pandutwa, duration og play, aruchi, shwasa, hridyaspandan, shotha, constipation. |
30 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/10/2024 |
| 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
|
The study will be intervened by the treatment of Dashamoola Syrup and Iron Syrup to group A and group B respectively. The efficacy of the therapy will be assessed on the
basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity
of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of
each symptom will be calculated before treatment, after treatment and after follow up. The effect of
treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading
and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring
method. |