| CTRI Number |
CTRI/2025/01/079174 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of khadir plant in treating people suffering from anemia. |
|
Scientific Title of Study
|
An Investigation on Khadir (Acacia catechu) as a Potential Haematinic Agent in Phenyl Hydrazine Induced Anaemia in rats and clinical Study on Pandu (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 Amit Kumar Taraphdar |
| Designation |
Professor,Dept. of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P |
| Address |
Dept. of Dravyaguna Vijnana,Room No.T2,Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P.
294/3/1,A.P.C. Road,Kolkata.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Taraphdar |
| Designation |
Professor,Dept. of Dravyaguna Vijnana |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P |
| Address |
Dept. of Dravyaguna Vijnana,Room No.T2,Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P.
294/3/1,A.P.C. Road,Kolkata.
Kolkata
WEST BENGAL
700009
India |
| Phone |
9874849650 |
| Fax |
|
| Email |
atipgaer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tannawee Singh |
| Designation |
M.D Scholar. Dept. of Dravyaguna Vijnana. |
| Affiliation |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P |
| Address |
Dept. of Dravyaguna Vijnana,Room No.T2,Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P.
294/3/1,A.P.C. Road,Kolkata.
Kolkata
WEST BENGAL
700009
India |
| Phone |
8961914201 |
| Fax |
|
| Email |
tannaweekonnagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P |
|
|
Primary Sponsor
|
| Name |
Institute of Post Graduate Ayurvedic Education and Research at S.V.S.P |
| Address |
294/3/1 A.P.C Road,Kolkata-700009 |
| Type of Sponsor |
Government 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 |
| Dr Amit Kumar Taraphdar |
Institute Of Post Graduate Ayurvedic Education and Research at S.V.S.P. |
Room No. T2,Dept. of Dravyaguna 294/3/1,A.P.C Road,Kolkata,700009,kolkata,West Bengal
Kolkata
WEST BENGAL |
9874849650
atipgaer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE FOR CLINICAL TRIAL ON HUMAN SUBJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D539||Nutritional anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Livogen xt tablet | Elemental iron -100 mg
folic acid -1500 mcg
elemental zinc - 22.5 mg | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: khadir , Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: (2) Medicine Name: khadir , Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) newly diagnosed anemia within 2-6 month.
2) anemia will be considered in this study 6 mg/dl - 9 mg/dl. |
|
| ExclusionCriteria |
| Details |
1)any associated severe disease like hiv or tb or malignancy or trauma.
2)any medication like other anti anemic or anti pshycotic or steroids.
4)pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to access the haematinic property of khadir by monitoring the sign and symptoms as well as some laboratory investigations like hb% of the patient suffering from pandu roga |
sign and symptoms with hb % of the patients will be recorded after treatment after 14 days and finally after 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| effect of the test drug on quality of life among the patients of pandu roga. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
26/02/2025 |
| 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="0"
Months="8"
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 clinical study,which will take place at OPD of IPGAE&R at S.V.S.P hospital,is a randomized,parallel grouped control trial of a test drug comparing the efficacy of Livogen XT for 30 days in 20 patients with anaemia (pandu roga).The primary outcome of the research is to evaluate the therapeutic efficacy of the test drug for its potential in managing anemia.The secondary outcome is to determine the safety of test drug on quality of life among the patient suffering from anemia (pandu roga) |