| CTRI Number |
CTRI/2020/09/027751 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
05/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Result of polyherbal Leha for children suffering from stuttering |
|
Scientific Title of Study
|
A comparative study of Guduchyadi Leha and Kalyanak Leha in management of Gadgada (Stuttering) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Megha Dipak Rudey |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7057291880 |
| Fax |
|
| Email |
megharudey121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Renu Bharat Rathi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9373703816 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Renu Bharat Rathi |
| Designation |
Professor |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9373703816 |
| Fax |
|
| Email |
rbr.226@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical Sciences (Deemed to be University), Sawangi (Meghe), Wardha |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Center |
| Address |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha, Maharashtra, 442001, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Megha Dipak Rudey |
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha |
Kaumarbhritya Department, Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod (Hi), Wardha
Wardha
MAHARASHTRA |
7057291880
megharudey121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Salod (H), Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guduchyadi Leha |
dose - 2-5 years: 0.5 - 1 gm TDS
6-12 years: 2.5 gm BD
Anupan - Honey
Jivha Pratisarana Duration up to 2 minutes for 45 days
Follow-up on 15th, 30th, 45th day
|
| Comparator Agent |
Kalyanak Leha |
Dose and Frequency - 2-5 years: 0.5 -1 gm TDS
6-12 years: 2.5 gm BD
Anupan - Honey
Jivha Pratisarana Duration up to 2 minutes for 45 days Follow-up - 15th, 30th, 45th day
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients with age group of 2 years to 12 years will be taken.
b. Children with clinical manifestations of speech impairment i.e. stuttering will include in the study.
c. Patients will be selected irrespective of gender, religion, socioeconomic status.
d. Patients with diagnosed delayed development of speech as sequel of neurological disorder which is cured.
|
|
| ExclusionCriteria |
| Details |
a. Deaf children will be excluded
b. Children with severe infection, brain trauma
c. Patients suffering from cleft palate & cleft lip or the conditions where the surgical intervention is required
d. Patient suffering from Stomatitis.
e. Children not speaking small sentence.
f. Children suffering from Autism Spectrum disorder.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the Speech fluency along with reduction of pitch, frequency and duration of the stuttered words or the tone of the stutterer is expected. |
15th, 30th, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of stuttering, Duration of stuttering will be reduced, Physical Concomitants, Speech naturalness will improved |
15th, 30th, 45th day |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/10/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group study comparing the safety and efficacy of Guduchyadi leha and Kalyanak Leha in the childrens who are suffering from stuttering. This study will be conducted in Mahtama Gandhi Ayurved College, Hospital and Research Center, Salod (Hi). The outcome of the this study will be reduction in the stuttering in 45 days of treatment period. |