| CTRI Number |
CTRI/2024/11/076668 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Pharmaceutical And Clinical Study of Kasisa Godanti Bhasma Capsule in Iron Deficiency Anaemia |
|
Scientific Title of Study
|
A Pharmaceutical and Clinical Evaluation Of Kasisa Godanti Bhasma Capsule in the Management of Pandu Roga with Special Reference to Iron Deficiency Anaemia |
| 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 Shivani Khantwal |
| Designation |
MD Scholar Rasashastra And Bhaishajya Kalpana |
| Affiliation |
Government P.G Ayurvedic College And Hospital,Varanasi,Uttar Pradesh 221002 |
| Address |
Government P.G Ayurvedic College And Hospital,Varanasi,Uttar Pradesh 221002
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
7060998824 |
| Fax |
|
| Email |
shivanikhantwal08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Richa Pathak |
| Designation |
Lecturer |
| Affiliation |
Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001 |
| Address |
Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
8948883359 |
| Fax |
|
| Email |
Richapathak384@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Mishra |
| Designation |
Lecturer |
| Affiliation |
Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001 |
| Address |
Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9721217773 |
| Fax |
|
| Email |
Drshwetamishraaiia@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Department of Rasashashtra Evam Bhaishajya Kalpana,Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001 |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurvedic College and HospitalVaranasiUttar Pradesh |
| Address |
Department of Rasashashtra Evam Bhaishajya Kalpana,Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shivani Khantwal |
Government P.G Ayurvedic College and Hospital,Varanasi,Uttar Pradesh 221001 |
Department of Rasashashtra Evam Bhaishajya Kalpana
Varanasi
UTTAR PRADESH |
7060998824
Shivanikhantwal08@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,GOVERNMENT P.G. AYURVEDIC COLLEGE AND HOSPI TAL,VARANASI,U.P, MAHAYOGI GURU GORAKHNATH AYUSH UNIVERSITY, GORAKHPUR,U.P |
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: KASISA GODANTI BHASMA, Reference: RASATANTRASARA EVAM SIDDHA PRAYOG SANGRAHA, Route: Oral, Dosage Form: Bhasma, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | IRON SUPPLEMENT | ROUTE-ORAL
DOSAGE-TABLETS
DOSE-100 MG
FREQUENCY-BID
DURATION-45 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of age group 16 to 60 years irrespective of gender, religion, occupation
2)Patients having signs and symptoms of panduroga without any complications.
3)Haemoglobin percentage in between 7gm/dl to 11gm/dl.
4)Patients with samanaya lakshana of pandu roga |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from tuberculosis Diabetes mellitus or other severe disease.2)Age below 16 years and more than 60 years
3)Haemoglobin less than7gm/dl
4)Anemia due to causes other than iron deficiency like Thalassemia, Sickle cell anaemia Aplastic anaemia, Megaloblastic anaemia, anaemia due to bleeding disorders and Leukemia
5)Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Anaemia |
15 Days,30 Days,45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete Relief from Anaemia |
45 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 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| 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="2"
Months="2"
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 Interventional Study Trial Comparing The
Efficacy Of Kasisa Godanti Bhasma Capsule With That Of Iron Supplement In The
Patients Of Iron Deficiency Anaemia.
The Patients Will Be Randomly Selected From Opd Of
Department Of Rasashastra And Bhaishajya Kalpana And Kayachikitsa At Government
P.G Ayurvedic College And Hospital ,Varanasi.
60 Patients Will Be Studied Under 2 Groups Having 30
Patients In Each Group.
Group A- 30 Patients Will Be Treated By Kasisa Godanti
Bhasma Capsule For 45 Days.
Group B-30 Patients Will Be Treated By Iron Supplement For
45 Days.
The Followup Will Be Done After Every 15 Days Of Treatment
In Each Group.
Total Duration Of Treatment Plan Is 45 Days
|