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CTRI Number  CTRI/2022/04/042128 [Registered on: 25/04/2022] Trial Registered Prospectively
Last Modified On: 24/04/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   A clinical trial on ayurvedic formulation in the management of Garbhini Pandu w.s.r Anaemia in Pregnancy. 
Scientific Title of Study   Role of Punarnava Mandura with and without Shatavari Avaleha in Garbhini Pandu with special reference to Anaemia in pregnancy- a randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonia Sharma 
Designation  PG Scholar 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA 
Address  Ward no.19 Hanuman Chawk Suratgarh
Department of Prasutitantra evam Striroga, National Institute of Ayurveda (Deemed to be University), Jorawarsingh gate, Jaipur, Rajasthan
Ganganagar
RAJASTHAN
335804
India 
Phone  8005696282  
Fax    
Email  sonia.sharmasog@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B Pushpalatha 
Designation  Associate Professor 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA 
Address  Department of Prasutitantra evam Striroga, National Institute of Ayurveda (Deemed to be University), Jorawarsingh gate
Department of Prasutitantra evam Striroga, National Institute of Ayurveda (Deemed to be University), Jorawarsingh gate
Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B Pushpalatha 
Designation  Associate Professor 
Affiliation  NATIONAL INSTITUTE OF AYURVEDA 
Address  Department of Prasutitantra evam Striroga, National Institute of Ayurveda (Deemed to be University), Jorawarsingh gate
Department of Prasutitantra evam Striroga, National Institute of Ayurveda (Deemed to be University), Jorawarsingh gate
Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Pharmacy, Jaipur, Rajasthan 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda (Deemed to be University), Jorawarsingh gate, Jaipur, Rajasthan-302002 
Type of Sponsor  Other [Government Ayurveda College] 
 
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 
Dr Sonia Sharma  National Institute of Ayurveda, Jaipur and associated hospitals  Department of Prasuti Tantra & Stri Roga, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN 
8005696282

sonia.sharmasog@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:O990||Anemia complicating pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Punarnava Mandura, Reference: Charak Samhita, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Shatavari Avaleha), Additional Information: Shatavari Avaleha to be taken 1 hour before meal with milk followed by Punarnava Mandura 30 mins before meal.
2Comparator ArmDrugClassical(1) Medicine Name: Punarnava Mandura, Reference: Charaka Samhita, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1.A pregnant woman aged between 20-40 years with anaemia in between 13th to 28th week of pregnancy.
2. Pregnant woman with haemoglobin percentage 7.0-10.00 gm/dl (moderate anaemia) 
 
ExclusionCriteria 
Details  1.Anaemia other than iron deficiency anaemia.
2. Patients having haemoglobin percentage less than 7.0 gm/dl.
3. Patients suffering from any systemic disease.
4. Patients suffering from pregnancy related complication such as pregnancy induced hypertensive disorders, hyperemesis gravidarum, gestational diabetes etc.
5. Pregnancy associated with Rh Incompatibility, Jaundice,Ovarian tumour, Placenta Previa, abruptio Placenta, fibroid with pregnancy etc 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Achievement of more than 10gm/dl Haemoglobin  2 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improvement in quality of life – SF 36.
2. Changes in Complete blood count (CBC), Serum iron, Total iron
binding capacity (TIBC), Serum ferritin.
3. Changes in associated symptoms like Shrama (fatigue), Panduta
(pallor), Daurbalya (general weakness), Shwasa (dyspnea),
Hridspandana (palpitations), Aruchi (anorexia), Akshikuta Shoth
(periorbital edema), Pindikodveshthana (leg cramps), Bhrama
(giddiness).
 
2 MONTHS 
 
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)   02/05/2022 
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   NILL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   PRIMARY PURPOSE: Treatment 
NEED OF STUDY: According to the WHO, anaemia affects 14% of pregnant women in developed and 51% in developing countries. It is painful to mention that India accounts for almost 80% of maternal fatalities in South Asia owing to anaemia. Anaemia during pregnancy has been linked to poor maternal and child health, as well as a higher risk of maternal and perinatal mortality. Fatigue, poor work capacity, increased risk of cardiac disease and mortality are all unfavourable health implications for the mother. Preterm birth and low birth weight babies are associated to anaemia in pregnancy. It is also associated with increased risk of intrauterine deaths, low APGAR score and intrauterine growth restriction (IUGR).[10] Anaemia is commonly due to dietary deficiency (nutrition, iron, folic acid, iodine and other micronutrients) or infections.[11] Acharya Charaka has said that Raktadi dhatus get vitiated by Doshas, mainly by Pitta dosha and disease like Pandu appear. There is no direct formulations available for the management of Garbhini Pandu in Ayurveda Samhitas. The line of treatment in Pandu is Shodhana, but it is contraindicated during pregnancy. Therefore, appropriate Shamana Chikitsa has to be adopted. On the basis of Pandughnata (antianaemic), Preenana (nourishing) and Raktaprasadana (blood toner) properties Punarnava Mandura is found useful for the management of all types of Pandu. Hence to prevent various complications of anaemia in pregnancy, to provide a safe management to the pregnant lady and to study the efficacy of indigenous compound this research work is undertaken. 
AIM: ï‚· To assess the role of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu. 
OBJECTIVES: Primary Objectives: • To assess and compare the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu. Secondary Objectives: 1. To assess the improvement in quality of life. 2. To assess the improvement in associated symptoms of Garbhini pandu such as Shrama (fatigue), Panduta (pallor), Daurbalya (general weakness), Shwasa (dyspnea), Hridspandana (palpitations), Aruchi (anorexia), Akshikuta Shoth (periorbital edema), Pindikodveshthana (leg cramps), Bhrama (giddiness). 
HYPOTHESIS: 
ï‚· NULL HYPOTHESIS (H0): There is no difference in the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu.
ï‚· ALTERNATIVE HYPOTHESIS (H1): There is significant difference in the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu. 
ï‚· RESEARCH QUESTION: Is there significant difference in the efficacy of Punarnava Mandura with and without Shatavari Avaleha in the management of Garbhini Pandu? 
ASSESSMENT CRITERIA: During the trial and follow up study the patients will be assessed on the basis of following parameters before and after the treatment. ï‚· Shrama (fatigue), Panduta (pallor), Daurbalya (general weakness), Shwasa (dyspnea), Hridspandana (palpitations), Aruchi (anorexia), Akshikuta Shoth (periorbital edema), Pindikodveshthana (leg cramps), Bhrama (giddiness). ï‚· Complete blood count (CBC), Haemoglobin percentage (Hb%), Serum iron, Total iron binding capacity (TIBC), Serum ferritin. 
LABORATORY INVESTIGATIONS: Before Treatment: • Complete blood count (CBC) • Peripheral blood smear (PBS) • Serum Iron • Total iron binding capacity (TIBC) Serum Ferritin • RFT - Blood Urea, Serum Creatinine • LFT - Total Serum Bilirubin, Serum Albumin, Total Protein • Other routine ANC investigations:  Blood group with Rhesus factor (ABO RH)  Human Immunodeficiency Virus (HIV)  Veneral disease research laboratory (VDRL)  Hepatitis B Surface Antigen (HbsAg) • Ultrasonography (USG) for fetal well being During Treatment: Haemoglobin After Treatment: ï‚· Complete blood count (CBC) ï‚· Serum iron ï‚· Total iron binding capacity (TIBC) ï‚· Serum ferritin 
 
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