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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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. | 2 | Comparator Arm | Drug | Classical | | (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 |