FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069318 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 11/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of ayurvedic formulation in garbhini pandu (anaemia in pregnancy) 
Scientific Title of Study   Randomized comparative trial to evaluate the effect of punarnava mandura with and without shatavari avaleha in garbhini pandu w.s.r. to iron deficiency anaemia in pregnancy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Mangal 
Designation  Pg Scholar 
Affiliation  National Institute Of Ayurveda Deemed To Be University (De-novo) Jaipur Rajasthan (302002) 
Address  Room No. 304 3rd Floor Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurverda Madhav Vilas Palace Amer Road Jaipur Rajasthan- 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8824673566  
Fax    
Email  dr.poojamangal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B Pushpalatha 
Designation  Professor 
Affiliation  National Institute Of Ayurveda Deemed To Be University (De-novo) Jaipur Rajasthan (302002) 
Address  Room No. 319 3rd Floor Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurverda Madhav Vilas Palace Amer Road Jaipur Rajasthan- 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pooja Mangal 
Designation  Pg Scholar 
Affiliation  National Institute Of Ayurveda Deemed To Be University (De-novo) Jaipur Rajasthan (302002) 
Address  Room No. 304 3rd Floor Department Of Prasuti Tantra Evum Stri Roga National Institute Of Ayurverda Madhav Vilas Palace Amer Road Jaipur Rajasthan- 302002

Jaipur
RAJASTHAN
302002
India 
Phone  8824673566  
Fax    
Email  dr.poojamangal@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Deemed To Be University (De Novo) Madhav Vilas Palace Amer Road Jaipur Rajasthan- 302002 India  
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda Deemed To Be University (De Novo) Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002 India 
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 
Dr Pooja Mangal  National Institute of Ayurveda, Jaipur And Associated hospitals  Department Of Prasuti Tantra Evum Stri Roga, National Institute of Ayurveda, Madhav Vilas Palace, Amer Road Jaipur, Rajasthan
Jaipur
RAJASTHAN 
8824673566

dr.poojamangal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda Deemed To Be University Madhav Vilas Palace Amer Road Jaipur Rajasthan 302002 India  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
1Comparator ArmDrugClassical(1) Medicine Name: Punarnava Mandura, Reference: API Part 2nd, Vol.3, Page No, 132-137, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Shatavari Avaleha, Reference: Reference Of Avaleha -Sharangdhar Madhyama Khanda 8/1-2, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Milk), Additional Information:
3Intervention ArmDrugClassical(1) Medicine Name: Punarnava Mandura, Reference: API Part 2nd, Vol.3, Page No, 132-137, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Water), Additional Information:
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. A pregnant woman aged between 21-40 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).
3. Pregnant woman with iron deficiency 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, pregnancy with fibroid 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 
Changes in haemoglobin level.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in quality of life.
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).
 
60 days 
 
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   Phase 3 
Date of First Enrollment (India)   01/07/2024 
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   N/A 
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, Anemia affects 14% of pregnant women in developed nations and 51% in developing countries. Mentioning the fact that anemia is the primary cause of about 80% of maternal deaths in South Asia occurs in India.
Poor maternal and fetal health, as well as a higher risk of maternal and postnatal mortality etc. have been connected to anaemia during pregnancy. For the mother’s health, fatigue, diminished productivity, a higher risk of cardiac disease, and mortality are all problems.
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).Anaemia is commonly due to dietary deficiency (nutrition, iron,
folic acid, iodine and other micronutrients) or infections. 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-
To evaluate the efficacy of punarnava mandura with and without shatavari avaleha in the management of garbhini pandu w.s.r. to iron deficiency anaemia in pregnancy.
Objectives-
Primary Objectives-
 To evaluate and compare the efficacy of Punarnava mandura with and without shatavari 
 avaleha in the management of garbhini pandu w.s.r.to iron deficiency anaemia in 
 pregnancy.
Secondary Objectives-
1 To assess the quality of life.
2 To assess presence or absence of 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).

Research Question- Is there any difference in the efficacy of Punarnava mandura with and without shatavari Avaleha in the management of garbhini pandu?

Hypothesis-
Null Hypothesis (H0)- There is no difference in the efficacy of Punarnava mandura with and without shatavari Avaleha in the management of garbhini pandu.
Alternative Hypothesis (H1)- There is 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.
1. Shrama (fatigue), Panduta (pallor), Daurbalya (general weakness), Shwasa (dyspnea),Hridspandana (palpitations), Aruchi (anorexia), Akshikuta Shoth (periorbital edema), Pindikodveshthana (leg cramps), Bhrama (giddiness).
2. 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), Venereal disease research laboratory (VDRL), Hepatitis B Surface Antigen (HbsAg), Ultrasonography (USG) for fetal well being
During Treatment- (After follow–up of one month)- Complete blood count (CBC)
After Treatment- Complete blood count (CBC), Serum iron, Total iron binding capacity (TIBC), Serum ferritin, Peripheral blood smear (PBS)
 
Close