| CTRI Number |
CTRI/2023/10/058275 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
26/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Baladi Ghrita along with Ferrous Ascorbate in the Treatment of Pica associated Anemia |
|
Scientific Title of Study
|
Study of add on effect of Baladi Ghrita along with ferrous ascorbate in the
management of Mridbhakshanjanya Pandu- A Randomized, Controlled, Clinical 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 Kiran Laxmanrao Kudmate |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and hospital, Vajirabad Nanded |
| Address |
Room no.47, Kaumarbhritya Department, Government Ayurved PG hostel, Vajirabad Nanded.
Kaumarbhritya Department, Government Ayurved College and Hospital,Vazirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
8552064766 |
| Fax |
|
| Email |
kirankudmate0118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Deokumar W Raut |
| Designation |
Assistant Professar |
| Affiliation |
Government Ayurved College and hospital Vajirabad Nanded |
| Address |
Kaumarbhritya Department, Government Ayurved College and
hospital, Vajirabad, Nanded-431601
Kaumarbhritya Department, Government Ayurved College and
hospital, Vajirabad, Nanded-431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
9823935698 |
| Fax |
|
| Email |
rautdeokumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deokumar W Raut |
| Designation |
Assistant Professar |
| Affiliation |
Government Ayurved College and hospital Vajirabad Nanded |
| Address |
Kaumarbhritya Department, Government Ayurved College and
hospital Nanded Vazirabad Nanded
Kaumarbhritya Department, Government Ayurved College and
hospital Nanded Vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9823935698 |
| Fax |
|
| Email |
rautdeokumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurved college and hospital Nanded Vajirabad square Nanded Maharashtra India |
|
|
Primary Sponsor
|
| Name |
DrKiran Laxmanrao Kudmate |
| Address |
ROOM NO. 47, Kaumarbhritya Department, Government Ayurved College and Hospital, Vazirabad, Nanded 431601 |
| 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 |
| DrKiran Laxmanrao Kudmate |
Government Ayurved College and Hospital |
Department of Kaumarbhritya, Government Ayurved College and hospital Nanded Vajirabad Nanded MAHARASHTRA INDIA Nanded
MAHARASHTRA
431601 India
Nanded
MAHARASHTRA |
8552064766
kirankudmate0118@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Baladi Ghrita, Reference: Gadnigraha Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 6(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous ascorbate | |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient will be selected irrespective of their gender, caste and socioeconomic status.
2. Patient’s age group between 2-6 years.
3. Hb% >8 gm/dl and <11gm/dl |
|
| ExclusionCriteria |
| Details |
1) Patient having any major systemic illness.
2) Patients below 2 year and above 6 years.
3) Patients with defective iron absorption in condition like gastrostomy, gastro-jejunostomy.
4) Anemia due to chronic illness like malaria, T.B, Leukemia, etc .
5) K/C/O Congenital anomalies, ADHD, Mentally retarded.
6) Hb% <8 gm/dl and >11 gm/dl |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Study of add on effect of Baladi Ghrita in the management of Mridbhakshanjanya Pandu
when given orally along with ferrous ascorbate on Pallor, Hb% , MCV, RDW-CV |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the clinical appearance of Mridbhakshanjany Pandu occurring in
Children according to both Ayurvedic & modern point of view. |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/10/2023 |
| 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="2"
Months="0"
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
|
This study is Randomized, Open labelled, Controlled, Clinical study of efficacy of add on effect Baladi Ghrita along with ferrous ascorbate in Mridbhakshanjanya Pandu when given orally for two months and follow up on 31st and 60th day. This study is conducted as PG course at single center. The primary outcome is to Study the add on effect of Baladi Ghrita in the management of Mridbhakshanjanya Pandu when given orally along with ferrous ascorbate on Pallor, Hb% , MCV, RDW-CV. |