| CTRI Number |
CTRI/2020/03/024120 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/02/2020 |
| 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
|
To Compare the efficacy of Dhatri Loha with tablet Ferrous Sulphate in Pandu (Anaemia) |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF DHATRI LOHA WITH TABLET FERROUS SULPHATE IN PANDU |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kashmira Vishnu Raikar |
| Designation |
PG student |
| Affiliation |
PDEAs college of Ayurved and Research Centre,Akurdi. |
| Address |
PDEAs college of Ayurved and Research Centre Akurdi
sect 25,3rd floor, Kaychikitsa department, opd no 117, Ayurved Rugnalay Sterling Multispeciality Hospital Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8796558521 |
| Fax |
|
| Email |
kashmiraraikar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Mahesh Joshi |
| Designation |
HOD and Guide Department of Kaychikitsa |
| Affiliation |
PDEAs college of Ayurved and Research Centre,Akurdi. |
| Address |
PDEAs college of Ayurved and Research Centre Akurdi
sect 25 Ayurved Rugnalay Sterling Multispeciality Hospital Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashmira Vishnu Raikar |
| Designation |
PG student |
| Affiliation |
PDEAs college of Ayurved and Research Centre,Akurdi. |
| Address |
PDEAs college of Ayurved and Research Centre Akurdi
sect 25, 3rd floor, Kaychikitsa department, opd no 117, Ayurved Rugnalay Sterling Multispeciality Hospital Nigdi Pune 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8796558521 |
| Fax |
|
| Email |
kashmiraraikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of Ayurved and Research Centre Nigdi Pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurved and Research Centre Nigdi Pune |
| Address |
PDEAs college of Ayurved and Research Centre Akurdi
sect 25 Nigdi Pune 411044 |
| 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 Kashmira Vishnu Raikar |
PDAyurved Rugnalay Sterling Multispeciality Hospital Nigdi Pune |
Ayurved Rugnalay Sterling Multispeciality Hospital sec 27,3rd floor, Kaychikitsa department, room no 32, Nigdi Pradhikaran Pune 411044
Pune
MAHARASHTRA |
8796558521
kashmiraraikar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D50-D89||Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dhatri Loha 500mg |
Dhatri Loha is prepared as per Ayurverd Text.Dose 500mg twice a day for two months.Route Oral |
| Comparator Agent |
Tablet ferrous sulphate |
Tablet ferrous sulphate 200mg once a day for two months Route Oral |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
patients having following symptoms
Panduta, Ayasenshwas, akshikootshotha, agnimandya, bhrama |
|
| ExclusionCriteria |
| Details |
1 Anaemia associated with major systemic diseases like CCF, TB, CANCER, HIV,
2 Pregnant women, Lactating mothers
3 Mrudbhakshanjanya Pandu
4 Patient suffering from other types of anaemia like thalassemia, sickle cell anaemia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of Dhatri Loha 500mg twice a day with tablet ferrous sulphate 200mg once a day within 8 weaks. |
60 days with follow up on 15th, 30th, 45th and 60th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study the efficacy of Dhatri Loha
2 To compare efficacy of Dhatri loha with tablet ferrous sulphate
3 To study adverse effect if any |
60 days OR 8 Weaks with follow up on 15th, 30th, 45th and 60th day. |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/03/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
India is a developing country, it has relatively bigger number of health issues and malnutrition due to poverty, illiteracy or lack of heath services. Now a days anaemia is major problem in India and it affects approximately one third of the population. In modern science, anaemia means lower concentration of haemoglobin in blood. Multiple modern drugs are available but they gives some side effects also. Dietary modification is used as treatment but effective in very few patients. There is no work done on Dhatri loham and tablet Ferrous sulphate in Pandu, so these drugs and disease combination is selected. |