| CTRI Number |
CTRI/2024/11/076668 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| 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)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/11/2024 |
| Date of Study Completion (India) |
29/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Objective hematological parameters such as
Hb%, RBC count, MCV, MCH, MCHC, ESR, and PCV also improved significantly in
both groups. Group B showed comparatively greater improvement in hematological
indices, especially hemoglobin and RBC count, which may be due to the direct
action of iron supplementation on erythropoiesis and hemoglobin synthesis.
However, Group A also demonstrated considerable improvement, indicating
effective hematinic action along with correction of underlying metabolic
disturbances.
Overall assessment of therapy revealed that
marked improvement was observed in 63.33% of patients in Group A and 50% in
Group B. Moderate improvement was observed in 26.67% and 33.33% of patients
respectively. Very few patients showed mild or no improvement. These findings
indicate comparatively better overall clinical improvement in Group A.
|