| CTRI Number |
CTRI/2020/03/024042 [Registered on: 18/03/2020] Trial Registered Prospectively |
| Last Modified On: |
28/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF KALYANA AVALEHA AND SWEET FLAG POWDER IN
SPEECH DELAY IN CHILDREN
|
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY ON THE EFFECTIVENESS OF KALYANA AVALEHA AND VACHA CHOORNA IN
SPEECH DELAY 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 |
KAVYASREE B S |
| Designation |
PRELIMINARY MD (Ayu.) SCHOLAR |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN, KARANATAKA |
| Address |
DEPARTMENT OF KAUMARABHRITYA
SRI DHARMASTHALA MANJUNATHESHWARA
COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9447474287 |
| Fax |
|
| Email |
kavyaparameswaran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NAYAN KUMAR S |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN, KARANATAKA |
| Address |
DEPARTMENT OF KAUMARABHRITYA
SRI DHARMASTHALA MANJUNATHESHWARA
COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
8197589426 |
| Fax |
|
| Email |
drnayanpanaje@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAVYASREE B S |
| Designation |
PRELIMINARY MD (Ayu.) SCHOLAR |
| Affiliation |
SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN, KARANATAKA |
| Address |
DEPARTMENT OF KAUMARABHRITYA
SRI DHARMASTHALA MANJUNATHESHWARA
COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN
Hassan
KARNATAKA
573201
India |
| Phone |
9447474287 |
| Fax |
|
| Email |
kavyaparameswaran@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
|
|
Primary Sponsor
|
| Name |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
| Address |
DEPARTMENT OF KAUMARABHRITYA
SRI DHARMASTHALA MANJUNATHESHWARA
COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN
|
| 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 Kavyasree B S |
SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
DEPARTMENT OF KAUMARABHRITYA Sri Dharmasthala Manjunatheswara
College of Ayurveda and Hospital,
Hassan
Hassan
KARNATAKA |
9447474287
kavyaparameswaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHIC COMMITTEE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL, HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F809||Developmental disorder of speech and language, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kalyana avaleha |
Fine powders of Haridra,Vacha, Kushta, Pippali , Sunti ,Ajaji ,Ajamoda ,Yastimadhu and Saindhava will be made and mixed homogeneously and in the following dose
1.5 gms Twice Daily (2 to 5 Years)
: 2 gms Twice Daily (5 to 8 Years)
|
| Comparator Agent |
Vacha Choorna |
Fine powders of Vacha will be made and administered in the following dose
0.24 gms Twice Daily (2 to 5 Years)
: 0.32 gms Twice Daily (5 to 8 Years)
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1.Children of age group of 2-8 years fulfilling diagnosis of developmental delay in speech.
2.Children whose parents are willing to participate in the study after giving written consent form.
|
|
| ExclusionCriteria |
| Details |
1.Children with severe mental retardation.
2.Children with severe quadriplegic cerebral palasy.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare the effect of kalyana avaleha and vacha choorna in speech delay |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
27/03/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Kalyana avaleha is mentioned in
swarabheda adikara of Bhaishajya Ratnavali, where in elaborating on its
benefits author states; when consumed with sarpi is indicated in mooka, gadgada
& jadatwa and if consumed for a period of 21 days the person becomes sruthidara
and his voice becomes resonant and sweet4. Kalyana Avaleha consists
of slakshna churna of haridra, vaca, kusta, pippali, shunti, ajajee, ajamoda,
yastimadhu and saindhava in equal proportion w/w. Being kapha vata hara, the
formulation acts as srothoshodhaka & swarya. Vacha choorna act as medhya
and swaraprada. Vacha choorna is extensively used to enhance speech in folklore
practices. Hence an attempt is made to
compare the effectiveness of kalyana avaleha and vacha choorna in delayed
speech in children.
|