| CTRI Number |
CTRI/2024/03/064155 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
: A clinical trial to study the effect of japapushpa formulation (asava kalpana) in management of mild iron deficiency anaemia |
|
Scientific Title of Study
|
A single arm interventional study to determine the effectiveness of japapushpa guda a novel formulation for mild iron deficiency anemia and rakta saaratha
|
| 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 NISHA BABU |
| Designation |
Professor and HOD of Dravyagunavijnanam |
| Affiliation |
Kerala university of health science |
| Address |
Sree Narayana institute of ayurvedic studies and research first floor room no.13 department of dravyaguna
Sreenarayana institute of ayurvedic studies and research
Puthoor kollam
Kollam
KERALA
691513
India |
| Phone |
9656712927 |
| Fax |
|
| Email |
drnishaababu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NISHA BABU |
| Designation |
Professor and HOD of Dravyagunavijnanam |
| Affiliation |
Sree Narayana Institute of Ayurvedic science and research |
| Address |
Sree Narayana Health Care Society R Sankar Nagar Karimpinpuzha PO Pangode Puthur Kollam 691513 Kerala
Kollam
KERALA
691513
India |
| Phone |
9656712927 |
| Fax |
|
| Email |
drnishaababu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akarsha Sudhish |
| Designation |
Second professional BAMS junior student |
| Affiliation |
Kerala University Of Health Sciences |
| Address |
Kalavampara House, Valluvally, Koonammavu P.O,Eranakulam
Second professional BAMS junior student, Sree Narayana Institute of Ayurvedic Studies and Research, Puthoor, Kollam-691513 KERALA
Kollam
KERALA
683518
India |
| Phone |
9495787081 |
| Fax |
|
| Email |
akarshasudhish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Narayana Health Care Society R Sankar Nagar, Karimpinpuzha PO Pangode Puthur Kollam 691513 Kerala |
|
|
Primary Sponsor
|
| Name |
Sree Narayana Health Care Society |
| Address |
Sree Narayana Health Care Society R Sankar Nagar, Karimpinpuzha PO Pangode Puthur Kollam 691513 Kerala |
| Type of Sponsor |
Private 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 Nisha Babu |
Sree Narayana Institute of Ayurvedic Studies and Research Hospital |
Department of Kaya chikitsa, Room number – 8, Sree Narayana Institute of Ayurvedic Studies and Research Hospital, Puthoor, Kollam-691513 KERALA
Kollam
KERALA |
9656712927
drnishaababu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Narayana Institute of Ayurvedic Studies and Research-institutional ethics committee |
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 | Other than Classical | | (1) Medicine Name: Japa pushpa guda, Reference: NA, Route: Oral, Dosage Form: Gudpak, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: Japa pushpa guda is a new formulation. Properties of japa pushpa is mentioned in Ayurveda individually and properties of guda also. But the formulation is not explained.It is an anubhoota yoga, a formulation modified on basis of clinical efficacy by renowned Ayurvedic physicians |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Hb %9 g/dL - 12g/dL
students willing to participate in research |
|
| ExclusionCriteria |
| Details |
Pregnancy
Lactation
Piles
Bleeding disorders like hemorrhage
diabetics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| increase in amount of hemoglobin assessed through complete blood test after 8 weeks. |
base line : assessment of amount of hemoglobin and inclusion into the study
4 weeks : repeat assessment of amount of hemoglobin
8 weeks : last assessment of amount of hemoglobin |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase in rakta saarata score assessed through rakta saara assessment questionnaire |
base line : rakta saarata score assessment before intervention
4 weeks: rakta saarata score after 4 weeks of intervention
8 weeks: rakta saarata score after 8 weeks of intervention |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 an open labeled single arm clinical trial. Study aims to determine the effect of daily consumption of japa pushpa guda for management of mild iron deficiency anemia and rakta saarata. The primary outcome measure will be the increase in amount of haemoglobin within 4 weeks of treatment. |