| CTRI Number |
CTRI/2022/03/041003 [Registered on: 11/03/2022] Trial Registered Prospectively |
| Last Modified On: |
09/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Clinical Study of SHIGRU CHURNA AND RASAYANA YOGA ON ANAEMIA |
|
Scientific Title of Study
|
A Clinical Study of Some Indigenous Ayurvedic Drugs On Pandu Roga W.S.R to Iron Deficiency Anaemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Chaturvedi |
| Designation |
Pg Scholar in Department of Kayachikitsa |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved College Raipur |
| Address |
Department of kayachikitsa
Shri Narayana Prasad Awasthi Government Ayurveda College
Raipur
chattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827943560 |
| Fax |
|
| Email |
arushi_herbals@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Ojha |
| Designation |
Proffessor Department of Kayachikitsa |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurveda college Raipur |
| Address |
Department of Kayachikisa
Shri Narayana Prasad Awasthi Government Ayurveda College Raipur
Chattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Ojha |
| Designation |
Proffessor Department of Kayachikitsa |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurveda college Raipur |
| Address |
Department of Kayachikitsa
Shri Narayana Prasad Awasthi Government Ayurveda College Raipur
Chattisgarh
Raipur
CHHATTISGARH
492010
India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Narayan Prasad Awasthi Government Ayurveda College Raipur. |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa |
| Address |
Shri Narayana Prasad Awasthi Government Ayurveda College Raipur |
| 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 Rashmi Chaturvedi |
Shri Khudadad Doongaji Govt Ayurveda college hospital Raipur |
Department Of Kayachikitsa
G.E Road Raipur.chattisgarh
Raipur
CHHATTISGARH |
9827943560
arushi_herbals@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: Shigru Patra churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -shunthi siddha Jala), Additional Information: -(2) Medicine Name: Panchrasayana Yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 160 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients within Hb range of 6.5gm/dl to 10 gm/dl
patients of either sex.
patient with stable sickle cell Anaemia Within the range of 6.5gm/dlto 8gm/dl. |
|
| ExclusionCriteria |
| Details |
Patients with history of congenital Disorders related with Haemopoetic system like leukaemia ,Haemophilia,Thallesemia.
Patients of Acute cases of Malaria and Tuberculosis.
Patients suffering from Bleeding Disorders.
Lactating Mothers and Pregnant ladies.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
results will be studied
Haemoglobin every 15days |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| serum iron ,serum ferritin serum calcium ,LFT,RFT |
2 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2022 |
| 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="1"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Pandu Roga is the most common nutritional disorder in the World.IN this study Shigru Patra Churna and Panchrasayana yoga will be given to two groups of 30 patients each.2 months research study and 2 months Follow Up for each group will be followed.In 15 days the patients will be called for follow up. During the research study the change in Haemoglobin and other parameters such as Serum Calcium, Serum Iron, serum Ferritin will be studied.after completion of Research study 2 months follow up period will be followed for any further developments after completion of Trial. Group A will be given Shigru Patra churns with Shunthi Siddha Jai. Group B will be given Panchrasayan Yoga with milk |