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CTRI Number  CTRI/2019/06/019626 [Registered on: 11/06/2019] Trial Registered Prospectively
Last Modified On: 07/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Punarnava Mandura with Shatavari Avaleha in Group A and Punarnava Mandura alone in Group B]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   TO ASSESS EFFICACY OF PUNARNAVA MANDURA WITH AND WITHOUT SHATAVARI AVALEHA IN PREGNANCY ANAEMIA  
Scientific Title of Study   A RANDOMIZED COMPARATIVE CLINICAL STUDY TO ASSESS EFFICACY OF PUNARNAVA MANDURA WITH AND WITHOUT SHATAVARI AVALEHA IN GARBHINI PANDU 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Moushami Kulhare 
Designation  P.G. Scholar 
Affiliation  National Institute Of Ayurveda 
Address  PG Department Of Prasuti Tantra evam Stri Roga Vigyana National Institute Of Ayurveda Jaipur
Jorawar singh gate N.I.A girls hostel
Jaipur
RAJASTHAN
302002
India 
Phone  9926318857  
Fax    
Email  drmoushami@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof K Bharathi 
Designation  Head Of Department 
Affiliation  National Institute of Ayurveda Jaipur 
Address  PG Department of Prasuti Tantra evam Stri Roga Vigyana National Institute of Ayurveda Jaipur
PG Department of Prasuti Tantra evam Stri Roga Vigyana National Institute of Ayurveda Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  9982678508  
Fax    
Email  baruhunt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Moushami Kulhare 
Designation  P G Scholar 
Affiliation  National Institute Of Ayurveda 
Address  PG Department Of Prasuti Tantra evam Stri Roga Vigyana National Institute Of Ayurveda Jaipur
Jorawar singh gate N.I.A girls hostel
Jaipur
RAJASTHAN
302002
India 
Phone  9926318857  
Fax    
Email  drmoushami@gmail.com  
 
Source of Monetary or Material Support  
National institute Of Ayurveda Jaipur 
 
Primary Sponsor  
Name  NIA 
Address  National Institute of Ayurveda Jorawar Singh Gate Jaipur Rajasthan Pin code 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Moushami Kulhare  National Institute of Ayurveda Jorawar Singh Gate Jaipur Rajasthan Pin code 302002 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Moushami Kulhare  National Institute Of Ayurveda  National Institute Of Ayurveda Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur 302002 Jaipur Rajasthan
Jaipur
RAJASTHAN 
9926318857

drmoushami@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Punarnava Mandura  Punarnava Mandura 500mg 2 times/day 30 min. before meals with Butter milk for 2 months  
Intervention  Punarnava Mandura and Shatavari Avaleha  Punarnava Mandura 500mg 2 times/day 30 min before meals with Butter milk. Shatavari Avaleha 5 gm 2 times/day with milk Duration- 2 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  A Pregnant woman with haemoglobin percentage 7.0-10.00 gm/dl, haematocrit less than 30%.
A pregnant woman with anaemia in 13th to 28th week of pregnancy.

 
 
ExclusionCriteria 
Details  Anaemia other than iron deficiency anaemia.
Patients having haemoglobin percentage less than 7.0 gm/dl.
Patients suffering from systemic diseases like Hypertension, Diabetes, Thyroid disorders, Liver disorders, Renal disorder, Cardio Vascular disorders, Cerebro-Vascular disorders, Tuberculosis etc.
Patients suffering from pregnancy related complications such as pregnancy induced hypertension, pre- eclampsia, eclampsia, hyper emesis gravidarum, gestational diabetes etc.
Pregnancy associated with Rh Incompatibility, Jaundice, Ovarian tumour, Placenta Previa, Abruptio Placenta.

 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu with special reference to improvement in haemoglobin percentage.

 

To assess the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu with special reference to improvement in haemoglobin percentage.Duration- 2 months

 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu with special reference to improvement in haemoglobin percentage.

 
To improve haemoglobin percentage in pregnant women.
To reduce consequences of preterm lobour and intra uterine growth retardation.
To reduce complications during labour.

 
 
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/ Phase 3 
Date of First Enrollment (India)   15/06/2019 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
 Pandu roga is one such disease which is found mentioned in Rigveda and Atharvaveda. 
According to Caraka Samhita Pandu roga is a disease of rasavaha srotas. There is no direct reference of Garbhini Pandu (anaemia in pregnancy) in Ayurvediya texts. Acharya Caraka in Sharira sthana has explained about Bala varna hani of garbhini in 6th month of pregnancy, which means feeling of weakness and loss of complexion. In symptoms of 7th month Acharya Chakrapani has mentioned Shonita hinta means low blood volume. All these symptoms are present in 2nd trimester of pregnancy and may be due to anaemia and can be considered as reference for Garbhini Pandu. Acharya Harita has described eight Garbhopadravas in  Harita  Samhita  and included Vivarnatva, which appears to be pallor that accompanies anaemia.  In  the  context  of  Raktagulma, Acharya Kashyapa  has  described  furnished  similar  description during  with  Garbhavastha  (pregnancy)  which  refers  to Garbhavasthajanya  Pandu.  The growing fetus is nourished by the Rasa of mother. So, mother needs a better and more nutritious diet.
    The disease Pandu has been described on the basis of its peculiar colour presentation as described by-
             Pandustu   peetbhagardham ketakidhoolisannibham (Shabdarnava)                                                                                                                  
India is one of the country with high prevalence of anemia during pregnancy. Iron deficiency anaemia is most common condition occurs in pregnant women. The global prevalence of anaemia among pregnant women is 55.9%. In India, the prevalence of anaemia in pregnant women has been reported to be in range of 33% to 89%. India contributes to about 80% of the maternal deaths due to anemia in South Asia.                                                                     
   Anaemia is classified as mild, moderate and severe based on the concentration of haemoglobin in the blood. Mild anaemia corresponds to a level of haemoglobin concentration of 10.0-10.9 gm/dl for pregnant women and 10.0-11.9 gm/dl for non pregnant women. Moderate anaemia corresponds to a level of 7.0-9.9 gm/dl, while severe anaemia corresponds to level less then7.0 gm/dl.
   Empirical use of different preparations of iron in the treatment of anaemia from ancient times is evident. Lauha Bhasma and Mandura Bhasma are effective in treating anaemia. On the basis of Pandughnata (antianaemic), Prinana(nourishing), Raktaprasadana(blood toner). Punarnava Mandura is successfully used by Ayurvediya physicians for the management of all types of Pandu and proved beneficial in Antenatal care by previous research works. 
 

 
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