| CTRI Number |
CTRI/2017/12/010739 [Registered on: 04/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
01/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
AN OPEN CLINICAL TRIAL TO ASSESS THE EFFICACY OF SHUNTHI CHURNA IN THE MANAGEMENT OF AGNIMANDYA W.S.R. TO LOSS OF APPETITE IN CHILDREN |
|
Scientific Title of Study
|
An open clinical trial to assess the efficacy of Shunthi churna in the management of Agnimandya w.s.r. to loss of appetite in children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAshwinkumar Akshaylal Soni |
| Designation |
P.G. Scholar |
| Affiliation |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya |
| Address |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9420776161 |
| Fax |
|
| Email |
dr.ashwinsoni25@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Azizahmed I Arbar |
| Designation |
Professor and Head of Kaumarbhritya department |
| Affiliation |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya |
| Address |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAshwinkumar Akshaylal Soni |
| Designation |
P.G. Scholar |
| Affiliation |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya |
| Address |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya
Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9420776161 |
| Fax |
|
| Email |
dr.ashwinsoni25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Ashwinkumar Soni,
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya
Shahapur, Belagavi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| DrAshwinkumar Soni |
K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya and Hospital |
K.L.E.U.’s Shri B.M.K.Ayurveda Mahavidyalaya,
Shahapur, Belagavi, Karnataka-590003
Belgaum
KARNATAKA |
9420776161
dr.ashwinsoni25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Agnimandya(Loss of appetite), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
SHUNTHI CHURNA |
SHUNTHI CHURNA IS AYURVEDIC DRUG MADE FROM ZINGIBER OFFICINALE, PART USED IS RHIZOME
Drug dose - 1gm twice in a day
Drug form - Churna
Route of administration - Orally
Anupana - Honey |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Children having age in between 14 to 16 years, irrespective to sex and religion.
2.Children presenting the features Agnimandya.
|
|
| ExclusionCriteria |
| Details |
1.Children having age less than 14 years and more than 16 years.
2.Patients suffering from any known acute or chronic illnesses that might interfere with study e.g acute infections, malignancies, thyroid problems etc.
3.Children having any associated life threatening medical or surgical disorders.
4.Children with any long term medications that may interfere with the result like for Diabetes etc will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shunthi churna will be effective in management of agnimandya in children. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find a safe and effective drug in the management of Agnimandya (Loss of appetite) in children |
15 DAYS |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/08/2017 |
| Date of Study Completion (India) |
10/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
YET TO BE PUBLISHED, WORK IS IN PROGRESS |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda
is a science of life & has its own identity as most ancient &
traditional system of Medicine. Sushrut defines health as “state of equilibrium
of doshas, agni ,dhatus, malas and homoeostasis of mind as well as
sensesâ€. Among this AGNI has its own importance for
the well being of an individual because according to ayurveda, all the diseases
are attributed to Agnimandya. In pediatric age group body needs
proper nutrition & diet. During this phase body undergoes lot of changes as
a result growth & development. Loss of appetite, dyspepsia is very common
symptom found in pediatric age group accounting to 50% children. Loss of
appetite is seen in association with constipation, worm infestation, B12
deficiency, UTI which are very common problems in children. Very few drugs are
available in modern science which are very specific as appetisers like
Cyproheptadine which has side effects like sedation etc. Loss of
appetite is a very common symptom in adolescents.
Therefore today there is a need to find a safe and
effective drug in the management of Agnimandya (Loss of appetite) in children. |