| CTRI Number |
CTRI/2025/01/079550 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study Of Vachadi Choorna And Kalyanaka Leha In The Management Of Speech Impairment In Children |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Vachadi Choorna And Kalyanaka Leha In The Management Of Speech Impairment(Mooka Minmina Gadgada) In Children |
| Trial Acronym |
not applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandani Sahu |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department Of Kaumarabhritya OPD NO.07 & IPD Patients Shri Khudadad Doongaji Government Ayurveda Hospital Raipur Chhattishgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
8349339489 |
| Fax |
|
| Email |
chandnisahu037@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prof Neeraj Agrawal |
| Designation |
Professor And HOD |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department Of Kaumarabhritya OPD NO.07 & IPD Patients Shri Khudadad Doongaji Government Ayurveda Hospital Raipur Chhattishgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lowkesh Chandrawansi |
| Designation |
Associate Professor |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G.) |
| Address |
Department Of Kaumarabhritya OPD NO.07 & IPD Patients Shri Khudadad Doongaji Government Ayurveda Hospital Raipur Chhattishgarh 492010
Raipur
CHHATTISGARH
492010
India |
| Phone |
9827822231 |
| Fax |
|
| Email |
lowkeshc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
RaipurDepartment Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurveda College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur (C.G)] |
|
|
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 Chandani Sahu |
Shri Khudadad Doongaji Government Hospital Raipur Chhattisgarh |
Department of Kaumarabhritya OPD No 07 and IPD Patient Shri Khudadad Doongaji Government Ayurveda Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
Raipur
CHHATTISGARH |
8349339489
chandnisahu037@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Govt. Ayurveda College Raipur Chhattisgarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R479||Unspecified speech disturbances. Ayurveda Condition: MUKATVAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vachadi Churna, Reference: Astanga Hridya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Madhu, Ghrita), Additional Information: 1) 3-6 yr- 1.5 gm/ day
2) 7-9 yr- 2 gm/ day
3) 10-12 yr - 2.5 gm/ day
(for 2 month)
| | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kalyanak Leha, Reference: Bhaisajya ratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: 1) 3-6 yr- 1.5 gm/day
2) 7-9 yr- 2 gm/day
3) 10-12 yr- 2.5 gm/day
(for 2 month) |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with age group 3 years to 12 years.
2.Children with clinical manifestations of speech impairment with and without cerebral palsy and other neurobehavioral disorders.
3.Patients will be selected irrespective of Gender,religion,socioeconomics status. |
|
| ExclusionCriteria |
| Details |
1.Patients below 3 years and above 12 years.
2.Children suffering from congenital,genetic disorder.
3.Patients suffering from mouth ulcer,cleft palate & cleft lip,tongue tie or the condition where the surgical intervention is required.
4.Speech disorders with other systemic disorders(nephrotic syndrome,diabities mellitus etc.) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduces The Symptoms Of Speech Impairment.
Helps in the Achieving of Language Milestones |
Intervention of medicine for 2 month and post treatment follow up after 1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improve the quality of life of child and parents
|
Intervention of medicine for 2 month and post treatment follow up after 1 month. |
|
|
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)
|
07/04/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Speech impairment is one of the common impairments presenting in early childhood.It can make the children difficult to communicate with other people and often affects a child’s quality of life.Mooka ,Minmina and Gadgada is mentioned in vatavyadhi avaran prakaran by acharya charak and acharya sushruta.In Astanga hridya uttartantra Acharya Vagbhata mentioned Vachadi churna for speech disorder.It has the properties of Anabhisyandi,Srotoshodhan Vatanuloman and vatakapha shamak which are the common treatment principle of avaran .The study is aimed to compare the efficacy of Vachadi churna and kalyanaka leha in the management of speech impairment in children.There will be 2 group each consist 20 patients.The study drug will be given to the intervention group and the standard drug will be given to the comparator group, in the form of leha ,oral (over the tongue) according to Young’s formula twice a day for 2 month.Post treatment follow up will be done in every 15 days for 1 month. Assessment will be done on the basis of subjective and objective criteria adopted for this study. |