| CTRI Number |
CTRI/2016/10/007373 [Registered on: 17/10/2016] Trial Registered Retrospectively |
| Last Modified On: |
15/10/2016 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
RASAYANA IN PREGNANCY |
|
Scientific Title of Study
|
ROLE OF MADHURAUSHADHA SIDDHA AVALEHA AS GARBHINI RASAYANA IN THE 6th AND 7th MONTH OF PREGNANCY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suprabha K |
| Designation |
MD Scholar |
| Affiliation |
SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
| Address |
SDM AYURVEDA COLLEGE AND HOSPITAL
KUTHPADY
UDYAVARA
UDUPI
KARNATAKA
Udupi
KARNATAKA
574118
India |
| Phone |
9164387950 |
| Fax |
9164387950 |
| Email |
sprbhk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MAMATHA KV |
| Designation |
PROFESSOR |
| Affiliation |
SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
| Address |
DEPT OF PRASUTITANTRA AND STREEROGA
SDM AYURVEDA COLLEGE AND HOSPITAL
KUTHPADY
UDYAVARA
UDUPI
Udupi
KARNATAKA
574118
India |
| Phone |
9448215605 |
| Fax |
|
| Email |
mamath2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MAMATHA KV |
| Designation |
PROFESSOR |
| Affiliation |
SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
| Address |
DEPT OF PRASUTITANTRA AND STREEROGA
SDM AYURVEDA COLLEGE AND HOSPITAL
KUTHPADY
UDYAVARA
UDUPI
KARNATAKA
574118
India |
| Phone |
9448215605 |
| Fax |
|
| Email |
mamath2@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
|
|
Primary Sponsor
|
| Name |
SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
| Address |
SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Suprabha K |
SDM AYURVEDA COLLEGE AND HOSPITAL KUTHPADY |
Department of prasuti tantra and stree roga, SDM AYURVEDA COLLEGE AND HOSPITAL, KUTHPADY, UDYAVARA,UDUPI
Udupi
KARNATAKA |
9164387950
sprbhk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical clearence committee-human |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PREGNANT PATIENTS COMPLETIONG 5TH MONTH OF PREGNANCY |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Iron and calcium supplements |
GROUP B : 15 patients
Calcium carbonate 500mg and Ferrous sulphate 200mg (containing 60 mg of elemental iron) are given daily once.
|
| Comparator Agent |
Madhuraushadha siddha avaleha |
GROUP A : 15 patients
Madhuraushadha siddha avaleha is administered in the dosage of 12 g, twice a day, once in the morning and in the evening, in empty stomach with ksheera as anupana
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Both Primi and Multi gravida will be included.
Subjects in their 20-24 weeks of pregnancy are selected.
Subjects having Hb% between 8-11 Grams
|
|
| ExclusionCriteria |
| Details |
Pregnancy complicated with intra uterine growth retardation, p/v bleeding, abruptio placenta, placenta previa, pre-eclampsia, oligo/polyhydraminos, multiple pregnancy, gestational diabetes, sickle cell anaemia, thalassaemia, co-existing fibroids.
Mal-absorptive diseases like chronic diarrhoea, dysentery, worm infestations.
Systemic diseases like hypertension, diabetes mellitus, human immuno deficiency virus infection, cardio vascular disorders, thyroid dysfunction, hepatitis B etc.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Madhuraushadha siddha avaleha as rasayana in pregnant lady and in the infant |
2 months of drug administration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of Madhuraushadha siddha avaleha on fetal and maternal immune system |
maternal immunity at end of 7th month
fetal immunity during delivery by cord blood analysis |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/01/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a randomised comparative clinical study on pregnant patients in their 6th month of pregnancy attending OPD/IPD of SDM hospital of ayurveda kuthpay udupi. Group A 15 patients administered madhuraushadha siddha avaleha for 60 days and Group B given routine Iron and calcium supplements for 2 months. Patients will be subjected to hematological test,maternal IgG IgM,sonography parameters, before and after the treatment and cord blood analysis for fetal IgG. .Result will be analysed on subjective and objective parameters and compared within and between the group |