| CTRI Number |
CTRI/2020/12/029796 [Registered on: 15/12/2020] Trial Registered Prospectively |
| Last Modified On: |
08/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of Vidaryadi Modaka in patients with karshya[underweight childern] |
|
Scientific Title of Study
|
“A CLINICAL STUDY TO EVALUATE THE EFFICACY OF VIDARYADI MODAK IN THE MANAGEMENT OF KARSHYA WITH SPECIAL REFERENCE TO UNDERWEIGHT CHILDREN†|
| Trial Acronym |
VMKC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pulkit Rai |
| Designation |
P G Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kaumarbhrutya Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9406775555 |
| Fax |
|
| Email |
pulkitrai31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swapnil C Raskar |
| Designation |
Associate Professor |
| Affiliation |
parul institute of ayurved |
| Address |
Department of Kaumarbhrutya Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9879340491 |
| Fax |
|
| Email |
neonatecare99@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pulkit Rai |
| Designation |
P G Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Kaumarbhrutya Parul Ayurved Hospital
Parul University AP Limda Tal Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9406775555 |
| Fax |
|
| Email |
pulkitrai31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of ayurved, Parul university Vadodara gujrat
|
|
|
Primary Sponsor
|
| Name |
Dean Faculty of Ayurved Parul University |
| Address |
Parul University AP Limda Tal Waghodia Vadodara Gujarat
|
| Type of Sponsor |
Private medical 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 Pulkit Rai |
Parul Institute of Ayurved |
Department of
Kayachikitsa Parul
Ayurved Hospital Parul
University AP Limda Tal
Waghodia Vadodara
Gujarat
Vadodara
GUJARAT
Vadodara
GUJARAT |
9406775555
pulkitrai31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| parul institute of ayurved-Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E46||Unspecified protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Vidaryadi modak 15 gm in two divided doses in 5 to 8 years and 25 gm in two divided doses in 9 to 10 years |
Vidaryadi modak is an
ayurvedic medicine having
reference in Bhavaprakash balaroga adhikar It contains Vidarikand[Pueraria tuberosa] Godhum[Triticum aestivu] Yava [Hordeum vulgare] Sugar Ghrita.
The medicine will be given in 15 gm in two divided doses in 5 to 8 years and 25 gm in two divided doses in 9 to 10 years for 60 days |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Subject within age group 5 to 10 years will be included in the study irrespective of Gender, caste and religion.
Subject with weight up to -2 SD for the expected weight for age.
|
|
| ExclusionCriteria |
| Details |
Patient associated with,
Chronic malnutrition.
Secondary malnutrition.
Congenital Diseases, Inborn Errors of Metabolism, Kwashiorkor or any other systemic illness with organic causes.
LBW babies whose catch-up growth is not attained.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is effective in the management of karshya in children. |
effect on karshya [underweight childern]
baseline and at the end of 15 days till 60 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Weight gain of patient |
effect on weight of karshya patients baseline and at the end of 15 days till 60 days
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
30/12/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Under nutrition is widely recognized as a major public
health problem in the developing countries worldwide. In the post-2015
developmental era, estimates of child malnutrition will help
determine whether the world is on track to achieve the Sustainable Developmental Goals to end hunger, achieve food security and
improved nutrition. Under nutrition denotes insufficient intake of energy and
nutrients to meet an individual’s need to maintain good health. According to Ayurveda, Karshya is
an Apatarpanjanya vyadhi, and results from Ruksh anapana, Langhana
and Pramitashana and can be correlated with undernutrition. Many
diseases are known to afflict human being such as the infectious, metabolic,
genetic and nutritional deficiency disorder. Out of these nutritional diseases
are by far the most common throughout the world, among them protein energy
malnutrition is the commonest one. It is the most widespread health and
nutritional problem in developing countries. A silent and largely invisible
emergency malnutrition plays a role in more than half of the nearly 11 million
deaths each year among children under age five. WHO identifies malnutrition as
the single most important risk factor for this disease |