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CTRI Number  CTRI/2020/02/023577 [Registered on: 25/02/2020] Trial Registered Prospectively
Last Modified On: 24/02/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to evaluate the effect of dhatri lauha in the management of garbhini pandu (iron deficiency anemia) 
Scientific Title of Study   An open label randomized controlled clinical trial to evaluate the effect of dhatri lauha in the management of garbhini pandu (iron deficiency amenia) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rekha solanki 
Designation  PG Scholar in Prasuti Tantra evam StrI Roga 
Affiliation  All india institute of ayurveda 
Address  All india institute of ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi South Delhi India

South
DELHI
110076
India 
Phone  9685382252  
Fax    
Email  rekhasolanki65214@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr sujata kadam 
Designation  MS(ayurveda)PhD in Prasuti Tantra evam Stri Roga 
Affiliation  All india institute of ayurveda 
Address  All india institute of ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi South Delhi India

South
DELHI
110076
India 
Phone  9890305370  
Fax    
Email  sujatadkadam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rekha solanki 
Designation  PG Scholar in Prasuti Tantra evam StrI Roga 
Affiliation  All india institute of ayurveda 
Address  All india institute of ayurveda Gautampuri Sarita Vihar Mathura Road New Delhi South Delhi India

South
DELHI
110076
India 
Phone  9685382252  
Fax    
Email  rekhasolanki65214@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Gautampuri,sarita vihar mathura raod New Delhi 
 
Primary Sponsor  
Name  All india institute of ayurveda 
Address  All india institute of ayurveda Gautampuri Sarita vihar Mathura Road New Delhi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rekha solanki  All India institute of ayurveda  Room no.202,second floor,hospital block,Prasuti Tantra evam Stri Roga Department,Gautampuri,Sarita Vihar,Mathura Road,New Delhi.76
South
DELHI 		 9685382252

rekhasolanki65214@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O280||Abnormal hematological finding onantenatal screening of mother,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dhatri lauha along with calcium tablet(calcium carbonate)   Dhatri lauha orally regularly for the period of pregnancy from 16th -18th weeks to till delivery with the doses of 250mg 2 tablet with water twice a day after meal,calcium tablet(calcium carbonate and vit D3)500mg OD for 6 months(12 weeks onwards to till delivery).  
Comparator Agent  Routine Antenatal care  iron capsule( ferrous ascorbate 100mg,folic acid 1.5mg)OD for 16-18 weeks onwards to till delivery),calcium tablet(calcium carbonate and vit.D3)500mg OD for 6 months(12 weeks onwards to till delivery). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  -pregnant women with gestational age 16-18 weeks,having Hb% equal or less than 10gm% but more than 7.5gm%.
-Microcytic hypocromic appearance of RBC in peripheral smear.
-pregnant women,belonging to the age group of 18 to 35 years having clinical singh and symptoms of pandu like -panduta,hrudrava,shwasa,shothas.
-Subjects willing to participate in the study and provide signed informed consent. 
 
ExclusionCriteria 
Details  -Pregnant women having Hb% count less than 7.5% and more than 10gm%.
-Pregnant women comeing with pregnancy related complications like PIH,hyperemesis gravidarum,pre eclampsia,diabetes,thyroid dysfunction etc.
-patients having high risk pregnancy.
-megaloblastic RBCs. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of dhatri lauha in garbhini pandu in change in haemoglobin level.  Hb% done after 15 days starting the treatment.if improved Hb% then will be continued again report 15th,20th,32th,36th,before term at the time of delivery. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of dhatri lauha in garbhini pandu in change in haemoglobin level.  Every 15th day in 4th to 6th month;every 8th day in 7th to 9th month 
 
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   Phase 2 
Date of First Enrollment (India)   01/03/2020 
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="6"
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)?  

Brief Summary   This is an open label randomized controlled clinical trial to evaluate the effect of oral administration of Dhatri lauha in a dose of 250mg 2 tablet twice a daily with pateble water in pregnant women from 16-18 weeks to till delivery on garbhini pandu. In one group Dhatri lauha along with calcium tablet(calcium carbonate) will be given and the other group will be given only the routine antenatal care. In Group A and B, other supplementary medicines and vaccination as per routine ANC Guidelines will be followed in Group A (without Iron tablet) and Group B. The study will be conducted in All india institute of Ayurveda ,New Delhi,India. The primary outcome measure will be to evaluate the effect of Dhatri lauha on Garbhini pandu in change in Hb% level.Hb% will be noted at the time of 15th day, 20th week, 28th week, 32th week,and just before delivery. The secondary outcome  measure will be to evaluate the effect of the drug on the change in hypochromic and microcytic RBCs, sign and symptoms of Garbhini pandu i.e daurbalya, hrudrava, shwasa, shoth. follow up will be on every 15th day in 4th to 6th month, every 8th day in 7th to 9th month. 
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