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CTRI Number  CTRI/2019/10/021592 [Registered on: 10/10/2019] Trial Registered Prospectively
Last Modified On: 26/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Efficacy of Lohasava and Amalaki Churna in the management of Anemia (Pandu) 
Scientific Title of Study   Clinical Evaluation of Lohasava and Amalaki Churna in the management of Iron Deficiency Anemia (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 Om Prakash 
Designation  Assistant Director Incharge 
Affiliation  Regional Ayurveda Research Institute for Drug Development. Aamkho, Gwalior 
Address  Room No. 35, Dept. of Ayurveda, Regional Ayurveda Research Institute for Drug Development, Aamkho, Gwalior, (M.P.) [Unit of CCRAS, New Delhi]

Gwalior
MADHYA PRADESH
474009
India 
Phone  09406581637  
Fax  07512430317  
Email  oprakash749@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Om Prakash 
Designation  Assistant Director Incharge 
Affiliation  Regional Ayurveda Research Institute for Drug Development. Aamkho, Gwalior 
Address  Room No. 35, Dept. of Ayurveda, Regional Ayurveda Research Institute for Drug Development, Aamkho, Gwalior, (M.P.) [Unit of CCRAS, New Delhi]

Gwalior
MADHYA PRADESH
474009
India 
Phone  09406581637  
Fax  07512430317  
Email  oprakash749@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Om Prakash 
Designation  Assistant Director Incharge 
Affiliation  Regional Ayurveda Research Institute for Drug Development. Aamkho, Gwalior 
Address  Room No. 35, Dept. of Ayurveda,Regional Ayurveda Research Institute for Drug Development, Aamkho, Gwalior, (M.P.) [Unit of CCRAS, New Delhi]

Gwalior
MADHYA PRADESH
474009
India 
Phone  09406581637  
Fax  07512430317  
Email  oprakash749@gmail.com  
 
Source of Monetary or Material Support  
Central Council For Research In Ayurvedic Sciences, Jawaharlal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhawan No. 61-65, Institutional Area, Janakpuri, New Delhi-110058  
Regional Ayurveda Research Institute for Drug Development, Aamkho, Gwalior (Unit of CCRAS)474009 
Regional Ayurveda Research Institute for Infectious Diseases, Agam kuan, Patna 800007 (Unit of CCRAS) 
 
Primary Sponsor  
Name  Central Council For Research In Ayurvedic Sciences 
Address  Jawaharlal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhawan No. 61-65, Institutional Area, Janakpuri, New Delhi-110058 
Type of Sponsor  Other [Autonomous research organisation under Ministry of AYUSH, Govt. of India ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Om Prakash  Regional Ayurveda Research Institute for Drug Development   Division of Ayurveda, Out patient Department, OPD room no 2, Aamkho, Gwalior 474009
Gwalior
MADHYA PRADESH 		 09406581637
07512430317
oprakash749@gmail.com 
Dr D S Rotwar  Regional Ayurveda Research Institute for Infectious Diseases   Division of Ayurveda, Out patient Department, OPD room no 13, D Block RMRI building Agam Kuan Patna
Patna
BIHAR 		 8827753466
06122631678
dsrotwar7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
RARIDD IEC  Approved 
RARIID IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Amalaki Churna  Dose-3gm Frequency-twice daily Route of Administration-Oral Time of Administration-twice daily after food Anupana-luke warm water Duration Therapy-12 weeks (84days)  
Intervention  Lohasava   Dose-20 ml mixed with equal amount of water Frequency-twice daily Route of Administration-Oral Time of Administration-twice daily after food Anupana-water Duration Therapy-12 weeks (84days)  
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. (i) Hb 8gm-10gm.%
(ii) S.Ferritin <13 µg/L(female) or <30 µg/L(male)
(iii) TIBC level >450mcg/dL
(iv) S.Iron<60μg/dL for male;<50 for female
(v) MCV level<80fL/red cell
(vi) RDW >46fL
(vii) Reticulocyte count <0.5%
(Among these the first 3 are the essential criteria for inclusion)
2. Willing and able to participate for 112 days.
 
 
ExclusionCriteria 
Details  1. Iron deficiency likely or definitely due to blood loss from the intestine or other sites.
2. History or evidence of intestinal malabsorption
3. Major co-morbidity such as a serious chronic medical condition unrelated to iron deficiency apparent on history, physical examination or laboratory tests
4. Other causes of anemia (sickle cell disease, thalassemia,other hemolytic anemia, bone marrow failure, etc.) apparent by history, physical examination, and/or laboratory tests
5. Liver enzymes, AST/ALT > 2 x the upper limit;serum creatinine more than the upper limit.
6. Patients on prolonged (> 6 weeks) medication that may have an influence on the outcome of the study
7. Other medical or social factors at discretion of treating physician
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Hemoglobin percentage  Baseline, and 84th day 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Serum ferritin level
Change in Serum iron level
Change in Ayurvedic Parameters of Pandu roga
Change in Peripheral Blood Smear Picture 		 Lab investigations on Baseline, and 84th day
Clinical assesment on Baseline, 14th, 28th, 42nd, 56th, 70th, 84th and 112nd day 
 
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   N/A 
Date of First Enrollment (India)   30/10/2019 
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="2"
Months="0"
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)?  

Brief Summary  

The nearest correlation of Pandu Roga can be made with iron deficiency anemia (IDA) in Modern system of medicine. Iron deficiency anemia arises when the balance of iron intake, iron stores and the body’s loss of iron are insufficient to fully support production of erythrocytes. As the IDA is a very common prevalent disease in the society and the side effects of oral modern iron preparations are very common, therefore to get a better alternative, an Ayurvedic herbomineral medicine,  Lohasava and Amalaki Churna, was chosen for a clinical trial in patients suffering from IDA.

Lohasava is a fermented formulation that contains lauha churna processed with some herbs as triphala, trikatu etc. Iron is absorbed more easily in its ferrous form and ferrous irons are formed in the acid conditions of gastric contents. Hence the formulations like Amalaki Churna helps to develop that media which can improve the iron absorption at gastric level and also acts as a carminative which reduces the mal- metabolism of food and body tissues. Amalaki is also known for its rasayana karma.

 
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