| CTRI Number |
CTRI/2020/12/029883 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Abhraloha tablets in anaemia |
|
Scientific Title of Study
|
Evaluation of efficacy and tolerability of Abhraloha tablets in iron deficiency anaemia – Phase IV study |
| Trial Acronym |
AIDA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Naresh Kishanrao Kore |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved & Research |
| Address |
Parul Institute of Ayurved & Research, Ishwarpura, Post Limda Taluka- Waghodiya, Vadodara, Gujarat
Ishwarpura. Post- Limda, Taluka- Waghodiya, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
08275174623 |
| Fax |
|
| Email |
naresh.kore86275@paruluniversity.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu Rajagopalaian Venkatachalaiah |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved
Post- Limda, Taluka- Waghodiya, Vadodara, Gujarat
Post- Limda, Taluka- Waghodiya, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9481328930 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisha Jagannath Munishwar |
| Designation |
Assitant Professor |
| Affiliation |
Parul Institute of Ayurved & Research |
| Address |
Parul Institute of Ayurved & Research
Ishwarpura. Post- Limda, Taluka- Waghodiya, Vadodara, Gujarat
Ishwarpura. Post- Limda, Taluka- Waghodiya, Vadodara, Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9766706395 |
| Fax |
|
| Email |
naresh.kore86275@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Shree Dhootapapeshwar Limited
135 Nanubhai Desai Road, Khetwadi,
Mumbai - 400 004
|
|
|
Primary Sponsor
|
| Name |
Shree Dhootapapeshwar Limited |
| Address |
135 Nanubhai Desai Road, Khetwadi,
Mumbai - 400 004
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Superitendent KAH |
Khemdas Ayurved Hospital, At-Ishwarpura, PO-Limda, TAQ-Waghodia, Dist-Vadodara, Gujarat |
| Superitendent PAH |
Parul Ayurved Hospital, Limda, Taq-Waghodia, Dist-Vadodara, Gujarat |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nisha Munishwar |
Khemdas Ayurved Hospital |
OPD No. 8, Ground floor, Khemdas Ayurved Hospital, Ishwarpura, Taluka-Waghodia, Vadodara 391760
Vadodara
GUJARAT |
9130642840
nisha.munishwar@paruluniversity.ac.in |
| Dr Shrinivas Dilaprao Jadhav |
Parul Ayurved Hospital |
opd no 106, ground floor,Parul Ayurved Hospital, Limda, Taluka- Wagodiya, Vadodara 391760
Vadodara
GUJARAT |
9945070999
shriniwas.jadhav260040@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe-PIA (IECHR) |
Approved |
| Institutional Ethical Committe-PIAR (IECHR) |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tab. Abhraloha |
It is an proprietary ayurvedic formulation used in the dose of 2 tab twice in a day in IDA.Treatment duration is 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients ready to give informed consent.
Patients of either gender between 18 to 50 years
Patients fulfilling diagnostic criteria
|
|
| ExclusionCriteria |
| Details |
Anemia other than Iron deficiency.
K/C/O Thalassemia, Myelodysplastic syndrome, Co-exsisting infection, Inflammation etc
K/C/O serious Hepatic, Renal, Pulmonary disease, malignancy etc.
Patients receiving treatment with any other hematinic drug or multivitamins will be excluded from study.
Pregnant and Lactating Woman
Past history of hypersensitivity to any of the ingredients of study medicine.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Hb % |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety assessed by incidence of adverse events and any abnormal laboratory parameters during the study duration. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 4 |
|
Date of First Enrollment (India)
|
30/12/2020 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Anemia is a condition in which number of RBC becomes insufficient consequently decreased ability of blood to carry oxygen to meet physiological needs of cell. The World Health Organization (WHO) describes iron-deficiency anemia as "the most common and widespread nutritional deficiency in the world." Prevalence of Anaemia is increasing in India and assessing the severity of the problem, it has been even included in the thrust area of health sectors governed by WHO and Ministry of AYUSH, Govt of India. Haemoglobin concentration lower than 12g/dL in women and 13g/dL in men is considered as Anemia. Prevalence of anemia is more in women and children. About 30 % world populations are anemic All over India, 70% population are anemic. In Gujarat and Vadodara, prevalence rate is 55.3% and 49.2% respectively.
This study is a multi-centric, prospective, Phase IV trial to evaluate the efficacy and tolerability of Abhraloha in Iron Deficiency Anemia. Abhraloha in the dose of 2 tablets twice times a day with lukewarm water after food for 2 months. Total duration of study is 12 months. There will be total 5 follow-ups during study which will be scheduled on every 15+-5 days. Study End Points are:Primary end point : Mean change in Hb % and Secondary end point: Safety assessed by incidence of adverse events and any abnormal laboratory parameters during the study duration. |