| CTRI Number |
CTRI/2025/10/096706 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect OF Mahasarasvati Churna In Improving Speech Problems In Pediatric Age (1-6 years) Group |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF MAHASARASVATI CHURNA IN SPEECH DISORDERS(MOOKA AND GADGADA)IN PEDIATRIC AGE GROUP |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul Yadav |
| Designation |
PG Scholar |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved college And Hospital Raipur Chhattisgarh |
| Address |
Department Of Kaumarbhritya OPD NO.10 & IPD Patients
Shri Khudadad Dungaji Government Ayurved Hospital Raipur chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
7898332721 |
| Fax |
|
| Email |
rahulyadav123.ry86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Neeraj Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved college And Hospital Raipur Chhattisgarh |
| Address |
Department Of Kaumarbhritya Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Neeraj Agrawal |
| Designation |
Professor and HOD |
| Affiliation |
Shri Narayana Prasad Awasthi Government Ayurved college And Hospital Raipur Chhattisgarh |
| Address |
Department Of Kaumarbhritya Shri Narayana Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India
Raipur
CHHATTISGARH
492010
India |
| Phone |
9109923485 |
| Fax |
|
| Email |
dr_neeraj2001in@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department Of Kaumarbhritya Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
| Address |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shri Narayan Prasad Awasthi Government Ayurved College Raipur |
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul Yadav |
Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh 492010 |
OPD NO.10 and IPD Department Of Kaumarbhritya Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH |
7898332721
rahulyadav123.ry86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR |
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. Ayurveda Condition: MUKATVAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahasarasvati Churna, Reference: Ras Ratna Samuchaya chap 24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Madhu - Ghrita), Additional Information: 1-2 years - 1gm (500mg BD)
3-4 Years - 2.5 gm (1.25gm BD)
5-6 years - 3gm (1.5 gm BD) |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients age group 1- 6 years
2 children with clinical manifestation of speech impairment with and without cerebal palsy and autism
3 patients will irrespective of gender , religion |
|
| ExclusionCriteria |
| Details |
1 patients below 1 years and above 6 years
2 child suffering from congenital , genetic disorders
3 patients suffering from cleft palate and cleft lips, tongue tie or the condition where the surgical intervention required |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce The Symptoms of Speech Impairment Helps in Achieving of Language Milestone |
Intervention of medicine for 3 month
(2 month for oral medication and 1 month for post treatment follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Imrpove the Quality of Life of child and parents |
Intervention of medicine for 3 month
(2 month for oral medication and 1 month for post treatment follow up |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
09/03/2026 |
| 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 disorder is a critical barometer of both cognitive and emotional development. Language development occurs most rapidly between 2 to 5 years of age. During this period of learning of speech, usually child begins repetition of consonants, often followed by repetition of words. If this condition continues then child suffers from disability of speech.This clinical study is designed to evaluate the efficacy of Mahasarasvati Churna in the management of pediatric speech disorders, specifically Mooka (speech impairment) and Gadgada (stammering), as described in Ayurveda. Eligible children within the pediatric age group presenting with speech disorders will be enrolled and administered Mahasarasvati Churna for a defined treatment duration. 3 month (2 month for oral medication and 1 month for post treatment follow up )The primary outcome will be improvement in speech clarity, fluency, and communication skills. Secondary outcomes will include changes in associated behavioral, cognitive, and developmental parameters. The study aims to generate clinical evidence to support the role of Mahasarasvati Churna in enhancing speech development and communication ability in children. Mahasarasvati Churna is a classical Ayurvedic formulation described in the text Rasa Ratna Samuchaya (Chapter 24). The formulation has also been included in the Ayurvedic Formulary of India (AFI), which authenticates its standard composition and therapeutic applicability. Its mention in both classical and official references highlights its traditional significance and contemporary relevance for clinical use in managing neurological and speech-related disorders. This is a randomized,single arm open label study. A total of 30 pediatric patients will be enrolled and allocated into two groups based on the type of speech disorder: Mooka and Gadgada, with 15 patients in each group. All patients in both groups will receive Mahasarasvati Churna in Leha form. The study aims to evaluate and compare the clinical efficacy of Mahasarasvati Churna in Leha form between the two types of speech disorders to determine in which condition it is more effective. |