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
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A RANDOMIZED COMPARATIVE CLINICAL STUDY TO ASSESS EFFICACY OF PUNARNAVA MANDURA WITH AND WITHOUT SHATAVARI AVALEHA IN GARBHINI PANDU |
Trial Acronym |
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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 |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
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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.
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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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