| CTRI Number |
CTRI/2024/04/065844 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use And Effect Of Raktamitraka In Pandu Roga (ANAEMIA) |
|
Scientific Title of Study
|
A Comparative Pharmaceutico-Analytical Study And Clinical Efficacy Of Raktamitrarka W.S.R. To Pandu Roga (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 Sandeep |
| Designation |
PG Scholar RSBK |
| Affiliation |
MMM.Goverment Ayurveda College Udaipur |
| Address |
Department of Rasshastra And Bhaishajya Kalpana MMM Goverment Ayurveda College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7073523228 |
| Fax |
|
| Email |
Sandeepmahla3228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
MMM.Goverment Ayurveda College Udaipur |
| Address |
Department of Rasshastra And Bhaishajya Kalpana MMM Goverment Ayurveda College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413257535 |
| Fax |
|
| Email |
sharmadrajay@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep |
| Designation |
PG Scholar RSBK |
| Affiliation |
MMM.Goverment Ayurveda College Udaipur |
| Address |
Department of Rasshastra And Bhaishajya Kalpana MMM Goverment Ayurveda College Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
7073523228 |
| Fax |
|
| Email |
Sandeepmahla3228@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM.Goverment Ayurved College Udaipur Rajasthan |
|
|
Primary Sponsor
|
| Name |
MMM Goverment Ayurveda College Udaipur |
| Address |
MMM. Goverment Ayurveda College Ambamata Udaipur Rajasthan |
| 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 Sandeep |
MMM Govt. Ayurveda College Udaipur |
OPD No:2
PG Department of Rasashastra and Bhaishajya kalpana
Udaipur
RAJASTHAN |
7073523228
Sandeepmahla3228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MMM. Goverment Ayurved College Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D649||Anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Raktamitraarka, Reference: Sidha bhaishajya manimala,fourth gucha,Pandu roga,294, Route: Oral, Dosage Form: Arka, Dose: 25(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: 50 ml luke warm water), Additional Information: All the ingredients will be collected and sealed in a earthern pot.Then pot will be covered with dung cakes and ignited by fire.This will be continued for 7 continous days.Ark will be obtained after heating the pot for 7 days over dung cakes. | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Raktamitraarka contemporary, Reference: NA, Route: Oral, Dosage Form: Arka, Dose: 25(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: 50 ml luke warm water), Additional Information: All the ingredients will be sealed in an earthern pot.The pot will be kept in electric furnace and heated for 7 continous days and ark will be obtained. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Sign and symptoms of Anaemia.
Evidence of Anaemia by lab investigations.
Participates in age group of 18-70 years.
Patients with Anaemia between 06gm %-10gm % of Haemoglobin |
|
| ExclusionCriteria |
| Details |
Patients suffered with serious cardiac disorders like MI, Cardiac failure and Crisis
Patients having life threatening disease.
Patient having major illness like IDDM, DM which is poorly controlled or newly diagnosed or is taking new therapy or recently adjusted therapy.
Patient having Carcinoma.
Pregnant lady.
Patient with severe Anaemia below 06 gm% of Haemoglobin.
Patient suffering with Thalassemia, Bone marrow disorders, autoimmune disorders and Iron toxicity.
Patient himself or herself wants to withdraw from the clinical trial. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Quantity of Haemoglobin |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anemia scale will be assessed |
15 days,30 days & 45 days |
|
|
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 2 |
|
Date of First Enrollment (India)
|
30/05/2024 |
| 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="6"
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 study is A Comparative Pharmaceutico - Analytical Study And Clinical Efficacy of Raktamitrarka W.S.R. To Pandu Roga ( Anaemia). There will be 2 groups in the study, In Group A randomly selected and clinically diagnosed 30 patients of Pandu roga whose Hb gm % will be of 06 to 10 gm % . Group A will be given Raktamitrarka prepared as per classical method and 30 patients of Group B randomly selected and clinically diagnosed will be given Raktamitrarka prepared by contemporary method. Trial will be conduct for a period of 2 months. Follow up of the case will be after every 15 days that is 4 times during treatment. Final assessment will be done after completion of 2 months course on the basis of subjective, objective and laboratoral assessment. The data will be analyzed scientifically and statistically. |