| CTRI Number |
CTRI/2018/08/015494 [Registered on: 28/08/2018] Trial Registered Prospectively |
| Last Modified On: |
21/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of shringyadi leha in cough in children |
|
Scientific Title of Study
|
EFFECT OF SHRINGYADI LEHA IN THE TREATMENT OF KAPHAJA KASA IN CHILDREN - A RANDOMIZED CONTROL CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MOHIT |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi |
| Address |
Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7206602956 |
| Fax |
|
| Email |
mmohitnarwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VEENA K H |
| Designation |
READER KAUMARBHRITYA DEPARTMENT |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi |
| Address |
Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9538469641 |
| Fax |
|
| Email |
dr.veenatonne@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr MOHIT |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi |
| Address |
Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi
Belgaum
KARNATAKA
590003
India |
| Phone |
7206602956 |
| Fax |
|
| Email |
mmohitnarwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAUMARBHRITYA OPD NO 10, KAHER,S SHRI BMK AYURVEDA MAHAVIDHYALAYA COLLEGE & HOSPITAL, SHAHPUR, BELGAVI |
|
|
Primary Sponsor
|
| Name |
Shri BMK Ayurveda Mahavidyalaya Shahpur Belgavi |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mohit |
Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mohit |
Department of Kumarbhritya OPD No 10 and IPD KLE Ayurveda Hospital |
KLE Ayurveda hospital Shahapur Belagavi Karnataka 590003
Belgaum
KARNATAKA |
7206602956
mmohitnarwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahpur, Belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
kaphaja kasa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shringyadi Leha |
•Shringyadi Leha - it contains the 3 ingredients - Karkatshringi ,Ativisha , Nagarmotha. Its reference is given in the text of Cakradatta Balrogaadhikara. It is used in kasa ,jvara, chhardi , ardita .DOSE- 4 YRS- 4 GMS,5YRS-5GMS AN D SO ON TILL 10 YRS-10 GMS
DURATION 7 DAYS, ANUPANA HONEY |
| Comparator Agent |
Talishadi churna |
Talishadi churna contains 8 contents. it is explained in the ayurvedic text of sharanghadhara samhita madhyamakhand in churnakalpana. its indications are -kasa ,swasa , jvara , chhard, atisaar, sosha , yakshma, pleeharoga, grahaniroga, panduroga, 4 YRS- 4 GMS,5YRS-5GMS AND SO ON TILL 10 YRS-10 GMS, DURATION 7 DAYS, ANUPANA HONEY
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children of either sex between the age group 4 years to 10 years
2. Patients with any of two or more symptoms
described in the context
3. KaphajaKasa of less than 15 days duration will be selected.
|
|
| ExclusionCriteria |
| Details |
1. Patients with kasa- except kaphajakasa.
2. Kasa as anubandh lakshana and updrava in other systemic diseases
3. Patients age below 4 years and above 10 years.
4. COPD cases and tuberculosis patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shringyadi leha may become safe and cost effective treatment for Kaphaja kasa, when compared to proven drug Talisadi churna which contains 7 ingredients and comparatively more costly.
Duration of treatment is less for 7days- may be effective in less period of time .
|
Shringyadi leha may become safe and cost effective treatment for Kaphaja kasa, when compared to proven drug Talisadi churna which contains 7 ingredients and comparatively more costly.
Duration of treatment is less for 7days- may be effective in less period of time .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of symptoms of Kaphaja Kasa within 7 days of duration. |
7 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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/09/2018 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Due to many environmental changes and less immune responses the respiratory tract infections are increasing day by day , among these 50% patients attends the pediatrics opd.At Primary Health Care Centres the study has been carried out by pediatrics department , in which 71% respiratory complaints are noticed, Recurrent attacks of kaphajakasa shows a prevalence rate of 1.06%, among them maximum no. of cases of study were seen in the age of 5 years to10 years, It is important to treat any disease in childhood age as the earliest as it may hamper the growth and development of the child.There are a large no. of expectorents drugs are available for management of cough in present time , but their bacterial resistance development and large no. of complications and side effects noticed day to day , So it’s better to give a safe and effective alternative management for this. According to Ayurveda , shaman line of treatment that included oral administration of medicine is very easy and also effective compared to shodhana in children.In this study we have planned to study subjects of kaphajakasa with combination of herbal drug and diet, Many herbal combinations for shaman chikitsa are described in Ayurveda and their therapeutic efficacy in kasa is yet to be explored, so the present study has been undertaken to evaluate the effect of shringyadileha to treat kaphajakasa in children
|