| CTRI Number |
CTRI/2025/02/081344 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study of Shigru Phal Churna on Raktalpata (Anemia) in Paediatric age group. |
|
Scientific Title of Study
|
Clinical Study of Shigru Phal Churna on Pandu Roga (lron Deficiency Anemia) in
Paediatric age group. |
| 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 Vinit Singh Jagat |
| Designation |
MD Scholar |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Kaumarabhritya OPD NO 07 and IPD Patients
Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827218875 |
| Fax |
|
| Email |
vinitjagat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Neeraj Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Kaumarabhritya OPD NO 07 and IPD Patients
Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lowkesh Chandravanshi |
| Designation |
Associate Professor |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department Of Kaumarabhritya OPD NO 07 and IPD Patients
Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College
Raipur Chhhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur
Chhhattisgarh 492010 |
| Type of Sponsor |
Other [Government Ayurved College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhhattisgarh |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur
Chhhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinit Singh Jagat |
Shri Khudadad Doongaji Government Ayurved Hospital Raipur Chhattisgarh 492010 |
OPD No.07 and IPD
Department Of
Kaumarbhritya Shri
Khudadad Doongaji
Government Ayurved
Hospital Raipur
Chhattisgarh 492010
Raipur
CHHATTISGARH |
9827218875
vinitjagat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GOVERNMENT AYURVED COLLEGE RAIPUR |
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: Shigru Phal churna, Reference: Sushruta Samhita Uttar Tantra Adhyaya 44, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ksheer), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Age from 4 to 12 years.
2.Both sex-male and female.
3.Children will be selected Mild to Moderate Iron Deficiency Anemia.
4.After obtaining written Assent from parents.
5.Children shows clinical features of Pandu roga. |
|
| ExclusionCriteria |
| Details |
1.Children suffering from any chronic or systemic disease like kidney disease, heart
disease,skin disease etc.
2.Chronic malnutrition.
3.Hb Level less than 8gm/dl.
4.Iron Deficiency Anemia with any associated Severe complication,
5.Other type of Anemia i.e. Sickle cell Anemia ,thalassemia etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hb % Increased in Final outcome |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Immunity boosted in final outcome |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/04/2025 |
| 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="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
|
Pandu is disease in which there is vaivarna or change of normal color of body.
Panduthva of the body is the main symptoms of Pandu Roga, Excessive intake of
Kshara(alkaline), Amla(Sour), Lavana(Salty), Ushna (Hot), Hriruddha(Incompatible), and
Asamya(Unsuitable) food. Pittadosha vitiation is the main causative factor, which then vitiates
Vata and KaphaDosha and the dushyas involved here. The Lakshanas of Pandu include
AlpaRakta, AlpaMeda, OjaKshaya, Shithilendriya, and also Vaivarnyata of the body.
Iron deficiency Anemia is a condition where lack of iron in the body lead to a reduction
in the number of red blood cells. Iron is used to produce red blood cells, which help store and
carry oxygen in the blood.
There are several different type of Anemia, and each one has a different cause. Iron
deficiency Anemia is the most common type.
Iron is an essential component of the hemoglobin molecule. The most common cause of
anemia worldwide is iron deficiency, which result in microcytic and hypochromic red cells on
the peripheral smear.
A prominent diagnostic feature of Pandu Roga is the pallor skin which occurs due to the
quantitative and qualitative deficiency of raktadhatu caused either in the form of deficiency of
hemoglobin and R.B.C. |