| CTRI Number |
CTRI/2022/01/039480 [Registered on: 17/01/2022] Trial Registered Prospectively |
| Last Modified On: |
14/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
EFFECT OF TRYUSHANADI MANDUR ON PANDU(ANAEMIA) |
|
Scientific Title of Study
|
PHARMACEUTICAL PREPARATION,STANDARDIZATION AND CLINICAL EFFICACY OF TRYUSHANADI MANDUR W.S.R TO PANDU ROGA(ANAEMIA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRADEEP DHAKED |
| Designation |
PG SCHOLAR |
| Affiliation |
MMM GOV.AYURVED COLLEGE |
| Address |
MMM GOV.AYURVED COLLEGE
UDAIPUR,RAJASTHAN
PIN:313001
NR DEVI G KA MANDIR
SANJAY NAGAR,BHARATPUR
RAJASTHAN
PIN:321001
Bharatpur
RAJASTHAN
313001
India |
| Phone |
9649605257 |
| Fax |
|
| Email |
dhakedpradeep48@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRAJAY KUMAR SHARMA |
| Designation |
ASSO.PROFESSOR |
| Affiliation |
MMM GOV.AYURVED COLLEGE |
| Address |
MMM GOV.AYURVED COLLEGE
UDAIPUR,RAJASTHAN
PIN:313001
Udaipur
RAJASTHAN
313001
India |
| Phone |
9413257535 |
| Fax |
|
| Email |
sharmadrajay@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PRADEEP DHAKED |
| Designation |
PG SCHOLAR |
| Affiliation |
MMM GOV.AYURVED COLLEGE |
| Address |
MMM GOV.AYURVED COLLEGE
UDAIPUR,RAJASTHAN
Udaipur
RAJASTHAN
313001
India |
| Phone |
9649605257 |
| Fax |
|
| Email |
dhakedpradeep48@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMM GOV.AYURVED COLLEGE
UDAIPUR,RAJASTHAN
|
|
|
Primary Sponsor
|
| Name |
MMM GOV AYURVED COLLEGE |
| Address |
MMM GOV.AYURVED COLLEGE
UDAIPUR,RAJASTHAN
PIN:313001
|
| 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 |
| PRADEEP DHAKED |
MMM GOV.AYURVED COLLEGE,UDAIPUR |
P.G Department of Rasashastra and Bhaishajyakalpana,Associated group of hospitals,MMM GOV.AYURVED COLLEGE,UDAIPUR.
Udaipur
RAJASTHAN |
9649605257
dhakedpradeep48@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,MMM GOV.AYURVED COLLEGE |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: TRYUSHANADI MANDUR, Reference: RASENDRA SARASANGRAHA, Route: Oral, Dosage Form: Bhasma, Dose: 12(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -HONEY), Additional Information: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Foods rich in iron.
Vegetables and Fruits., Apathya:Non vegeterian food. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)SIGNS AND SYMPTOMS OF ANEMIA
2)EVIDENCE OF ANEMIA BY LAB INVESTIGATION
|
|
| ExclusionCriteria |
| Details |
1)PREGNANT LADY
2)CARCINOMA
3)CARDIAC DISORDERS
4)IDDM,DM
5)BELOW 6gm%Hb |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)IMPROVEMENT IN SIGNS AND SYMPTOMS OF ANEMIA IN PATIENTS.
2)IMPROVEMENT IN COMPLETE HEAMOGRAM TEST |
2 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Improvement in signs and symptoms of anemia in patients. |
15 days,30 days,45 days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/01/2022 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS STUDY IS ABOUT EVALUATING THE EFFICACY OF TRYUSHANADI MANDUR IN THE MANAGEMENT OF PANDU ROGA W.S.R TO ANEMIA.THIS IS A RANDOMISED PARALLEL GROUP STUDY WHERE ONE GROUP OF 15 PATIENTS IS ADMINISTERED WITH TRYUSHANADI MANDUR -12 GM ,OD AND THE SECOND GROUP OF 15 PATIENTS WITH PLACEBO ALONG WITH CONTROLLED DIET FOR THE DURATION OF 2 MONTHS. |