| CTRI Number |
CTRI/2026/04/109467 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To test the effect of abhirumuladhi herbal drug in mentally unstable children
|
|
Scientific Title of Study
|
A clinical evaluation of abhirumuladi avaleha in the management of autism spectrum disorder (ASD) |
| 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 Jasmine |
| Designation |
PhD scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh
Partap Colony Street No. 1, Samana, Patiala Punjab.
Farrukhabad
UTTAR PRADESH
209602
India |
| Phone |
7717403473 |
| Fax |
|
| Email |
jasmineduggal2512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Darshana |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Desh Bhagat University, Mandi Gobindgarh, Punjab |
| Address |
Kaumarabhritya OPD, Desh Bhagat AYurvedic College and Hospital, DESH BHAGAT UNIVERSITY, Mandi Gobindgarh.
Fatehgarh Sahib
PUNJAB
147301
India |
| Phone |
8607507594 |
| Fax |
|
| Email |
dahiya.darshana222@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasmine |
| Designation |
PhD scholar |
| Affiliation |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh |
| Address |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh
Partap Colony Street No. 1, Samana, Patiala Punjab.
UTTAR PRADESH
209602
India |
| Phone |
7717403473 |
| Fax |
|
| Email |
jasmineduggal2512@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI BABU SINGH JAY SINGH AYURVEDIC MEDICAL COLLEGE AND HOSPITAL FARRUKHABADH |
|
|
Primary Sponsor
|
| Name |
Shri Babu Singh Jay Singh Ayurvediuc Medical College And Hospital |
| Address |
Shri Babu Singh Jay Singh Ayurvediuc Medical College And Hospital Farrukhabadh 209602 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jasmine |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh |
OPD NO. 26 Department of Balroga
Farrukhabad
UTTAR PRADESH |
07717403473
jasmineduggal2512@gmail.com |
| Dr Jasmine |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh |
Shri Babu Singh Jay Singh Ayurvedic Medical College And Hospital,Farrukhabadh
Partap Colony Street No. 1, Samana, Patiala Punjab.
Farrukhabad
UTTAR PRADESH |
07717403473
jasmineduggal2512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F808||Other developmental disorders of speech and language. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhirumuladi Avaleha, Reference: Aarogya Raksha Kalpa Dhrum, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 30(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects diagnosed with and presenting complaints of Autism will be taken.
2. Mild to moderate autistic patients will be taken.
3.From the age group of 5 to 16 years of subjects irrespective of gender, caste, socioeconomic status and food habits will be taken.
4.Parents/ guardian willing to give informed written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Children below 5 years and above 16 years.
2.Severe Autistic Patients.
3.Hearing and visual impairment, Multiple disabilities.
4.Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus, malignancy, etc.
5.Progressive and non-progressive neuromuscular disorders, Known neurodegenerative disorder, Cerebral palsy.
6.Children taking anti-epileptic and anti-psychotic drugs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| work on Hyperactivity, Aggressiveness, And Concentration |
45 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IT WILL IMPROVE QUALITY OF LIFE OF AUTISTIC CHILDREN |
45 DAYS |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 3 |
|
Date of First Enrollment (India)
|
15/05/2026 |
| 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="26"
Months="5"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Autism spectrum disorder is a progressive neurodevelopmental disorder characterized by impaired social interaction, communication, and behavioral phenotypes. We are taking abhirumuladhi avleha in the management of ASD for research purposes. Contents of Abhirumuladhi Avleha are helpful to improve cognitive function, concentration and to enhance the quality of life of autistic children |