| CTRI Number |
CTRI/2019/11/021971 [Registered on: 11/11/2019] Trial Registered Prospectively |
| Last Modified On: |
05/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda Treatment for Childhood Infections |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED TRIAL ON THE EFFICACY OF ABHAYAM GHRITHAM AS LEHANA IN PREVENTING BALAGRAHA (WITH SPECIAL REFERENCE TO INFECTIONS) IN INFANTS BELOW 6 MONTHS |
| 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 Nazeema P K |
| Designation |
Professor |
| Affiliation |
Vaidyaratnam P S Varier Ayurveda College |
| Address |
Department of Kaumarabhritya
Vaidyaratnam P S Varier Ayurveda College
Edarikode PO
Kottakkal
Malappuram
Rasheed Mahal
Areekkad
Thalakkadathoor (PO)
Tirur, Malappuram
676 103
Malappuram
KERALA
676 501
India |
| Phone |
9495511081 |
| Fax |
|
| Email |
drnazimamday@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Ramachandran |
| Designation |
Professor and HOD |
| Affiliation |
Sree Narayana Institute of Ayurvedic Studies & Research |
| Address |
Department of Kaumarabhritya
Sree Narayana Institute of Ayurvedic Studies and Research Puthur
Kollam
Sree Narayana Institute of Ayurvedic Studies and Research Puthur
Kollam
691507
Malappuram
KERALA
691507
India |
| Phone |
9447243818 |
| Fax |
|
| Email |
drskram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nazeema P K |
| Designation |
Professor |
| Affiliation |
Vaidyaratnam P S Varier Ayurveda College |
| Address |
Department of Kaumarabhritya
Vaidyaratnam P S Varier Ayurveda College
Edarikode PO
Kottakkal
Malappuram
Rasheed Mahal
Areekkad
Thalakkadathoor (PO)
Tirur, Malappuram
676 103
Malappuram
KERALA
676 501
India |
| Phone |
9495511081 |
| Fax |
|
| Email |
drnazimamday@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Hospital for Women and Children
poojappura, Thiruvananthapuram
Kerala, 695012 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Hospital for Women and Children |
| Address |
Government Ayurveda College Hospital for Women and Children
Poojappura
Thiruvananthapuram 695012 |
| Type of Sponsor |
Other [Government Ayurveda Medical College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nazeema P K |
Professor
Department of Kaumarabhritya
Vaidyaratnam P S Varier Ayurveda College
Edarikode PO
Kottakkal
Malappuram
676 501 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nazeema P K |
Government Ayurveda Medical College for Women and Children |
Department of Kaumarabhritya
Ayurveda College
Poojappura
Thiruvananthapuram
695012
Thiruvananthapuram
KERALA |
9495511081
drnazimamday@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC) |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The infants below 6 months of age of either gender attending for routine immunization as per National immunization schedule and having normal patterns of growth and development |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparison is done |
The children in control group were given the regular immunization schedule for the same period. |
| Intervention |
Ghritha panam with Abhaya Ghritha |
The children in trial group were given Abhaya Ghritha 2ml once daily on alternate days before feed in the morning, for a period of 30 days along with the regular immunization schedule.
dose-2ml
frequency - once daily before feed morning
route of administration - oral
duration of therapy-30 days |
|
|
Inclusion Criteria
|
| Age From |
45.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
The infants below 6 months of age of either gender attending for routine immunization as per National immunization schedule and having normal patterns of growth and development |
|
| ExclusionCriteria |
| Details |
Infants with congenital anomalies, birth injuries, neonatal complications, and other systemic illnesses |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced morbidity indices in terms of incidence and period prevalence rate |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in general health condition of infants |
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2019 |
| 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="1"
Months="6"
Days="23" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The clinical study is done to assess the efficacy of Abhaya ghritha in reducing the morbidity during the early infancy period by preventing affliction of Balagraha with special reference to infections. The children in the trial group were administered Abhaya Ghritha as per the dose schedule. Assessments of both the groups were done before and after the study and after a follow-up period of 60 days. The measures of morbidity indices were obtained using the incidence rate and period prevalence rate of infections. Growth and Nutritional status assessments were obtained using Weight, Length, Head Circumference, and Chest Circumference measurements. The aim of the study is intended to study the efficacy of Abhaya Ghritha in reducing the morbidity during the early infancy period by preventing affliction of Balagraha with special reference to infections. |