Autism Spectrum Disorder (ASD)Phase 4Pilot-RCT ASDNCT07054697
Pilot-RCT With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder
A Phase 4 study testing Homoeopathic medicines and THERAPY in people with Autism Spectrum Disorder (ASD), run by Aditi Chadha at 1 site in India.
Trial summary
This study looked at whether homeopathic treatment could help children with Autism Spectrum Disorder (ASD) when used alongside regular therapies like speech and occupational therapy. Over seven years, children between the ages of 2 and 12 were divided into two groups (through computer generated list). Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD)
- What is being tested?
- Homoeopathic medicines and THERAPY
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2017to 15 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A confirmed diagnosis of Autism Spectrum Disorder (ABC score ≥ 67)
- Age range of 2 to 12 years
Who cannot join
- Children with other significant comorbid psychiatric conditions that could confound the results. [eg. a brain injury; fragile X syndrome or other syndromes resulting from known genetic defects or inherited metabolic diseases; other diagnosed conditions involving impairments in social and communication abilities, such as intellectual disability without ASD, schizophrenia, language disorders and social communication disorder]
- Children with irregular follow ups.
- Children with poor medical compliance.
Trial locations and contacts
1 site in 1 country.
India1 site
Holistic Homoeopathic Clinic and Research Center
New Delhi, National Capital Territory of Delhi, 110024
About this study
Official title: A Single-blind Randomized Placebo Controlled Pilot Study With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder
This study looked at whether homeopathic treatment could help children with Autism Spectrum Disorder (ASD) when used alongside regular therapies like speech and occupational therapy. Over seven years, children between the ages of 2 and 12 were divided into two groups (through computer generated list). One group received individualized homeopathic medicines, and the other received a look-alike placebo (with no active ingredients). Meanwhile, both the groups continued with their regular therapies.
Researchers used various tools and parent questionnaires to track the children's progress in areas like communication, behavior, social skills, daily functioning, toilet training and sensory skills. They found that the children who received homeopathic treatment showed more improvement in these areas compared to those who just received only speech / occupational therapies.
- Conditions
- Autism Spectrum Disorder (ASD)
- Being tested
- Homoeopathic medicines, Placebo, THERAPY
- Keywords
- Homoeopathy, Autism Spectrum Disorder, Randomized Controlled Trial
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homoeopathic medicinesDrug
Also called THUJA OFFICINALIS, VACCININUM, CAUSTICUM, ARGENTUM NITRICUM
PlaceboDrug
Also called SACCHARUM LACTIS
THERAPYBehavioural
SPEECH THERAPY / OCCUPATIONAL THERAPY
| Study group | Role | What they receive |
|---|---|---|
| HOMOEOPATHIC GROUP | Experimental | Not described Receives: Drug: Homoeopathic medicines; Behavioral: THERAPY |
| CONTROL GROUP | Placebo comparator | SACCHARUM LACTIS Receives: Drug: Placebo; Behavioral: THERAPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childhood Autism Rating Scale (CARS)
To measure various behavioral dimensions and adaptive functioning
Measured: BASELINE, YEARLY (0-7 YEARS)
Autism Treatment Evaluation Checklist (ATEC)
To assess the efficacy of the treatment among both the arms.
Measured: BASELINE, YEARLY (0 - 7 YEARS)
Secondary outcomes (2)
Social Responsiveness Scale (SRS)
To measure social skills, communication abilities.
Measured: BASELINE, YEARLY (0 - 7 YEARS)
Neurodevelopmental Parent Report for Outcome Monitoring (ND PROM)
To gather subjective reports on their children's behavior, social interactions, and overall well-being from the parents.
Measured: BASELINE, YEARLY (0 - 7 YEARS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jan 2017
- Primary completion31 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aditi Chadha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aditi Chadha, Tatva Homoeopathic Clinic and Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054697
- Sponsor's protocol ID
- 20172024
- Acronym
- Pilot-RCT ASD
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: TO MAINTAIN CONFIDENTIALITY
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Randomized Placebo Controlled Pilot Study With Individualized Homeopathic Treatment in the Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07054697
- Acronym / sponsor ID
- Pilot-RCT ASD / 20172024
- Conditions
- Autism Spectrum Disorder (ASD)
- Keywords
- Homoeopathy, Autism Spectrum Disorder, Randomized Controlled Trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Aditi ChadhaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looked at whether homeopathic treatment could help children with Autism Spectrum Disorder (ASD) when used alongside regular therapies like speech and occupational therapy. Over seven years, children between the ages of 2 and 12 were divided into two groups (through computer generated list). One group received individualized homeopathic medicines, and the other received a look-alike placebo (with no active ingredients). Meanwhile, both the groups continued with their regular therapies.
Researchers used various tools and parent questionnaires to track the children's progress in areas like communication, behavior, social skills, daily functioning, toilet training and sensory skills. They found that the children who received homeopathic treatment showed more improvement in these areas compared to those who just received only speech / occupational therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOMOEOPATHIC GROUP | Experimental | Drug: Homoeopathic medicines, Behavioral: THERAPY |
| CONTROL GROUP | Placebo comparator | Drug: Placebo, Behavioral: THERAPYSACCHARUM LACTIS |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- A confirmed diagnosis of Autism Spectrum Disorder (ABC score ≥ 67)
- Age range of 2 to 12 years
Key exclusion criteria (3 listed)
- Children with other significant comorbid psychiatric conditions that could confound the results. [eg. a brain injury; fragile X syndrome or other syndromes resulting from known genetic defects or inherited metabolic diseases; other diagnosed conditions involving impairments in social and communication abilities, such as intellectual disability without ASD, schizophrenia, language disorders and social communication disorder]
- Children with irregular follow ups.
- Children with poor medical compliance.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Homoeopathic medicinesAlso: THUJA OFFICINALIS, VACCININUM, CAUSTICUM, ARGENTUM NITRICUM | Drug | HOMOEOPATHIC GROUP |
| PlaceboAlso: SACCHARUM LACTIS | Drug | CONTROL GROUP |
| THERAPYSPEECH THERAPY / OCCUPATIONAL THERAPY | Behavioural | CONTROL GROUP, HOMOEOPATHIC GROUP |
Primary outcome
Childhood Autism Rating Scale (CARS)
Time frame: BASELINE, YEARLY (0-7 YEARS)
To measure various behavioral dimensions and adaptive functioning
Autism Treatment Evaluation Checklist (ATEC)
Time frame: BASELINE, YEARLY (0 - 7 YEARS)
To assess the efficacy of the treatment among both the arms.
2 secondary outcomes
Social Responsiveness Scale (SRS)
Time frame: BASELINE, YEARLY (0 - 7 YEARS)
Neurodevelopmental Parent Report for Outcome Monitoring (ND PROM)
Time frame: BASELINE, YEARLY (0 - 7 YEARS)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: Undecided. TO MAINTAIN CONFIDENTIALITY
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Homoeopathic medicines and THERAPY in people with Autism Spectrum Disorder (ASD), run by Aditi Chadha at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood Autism Rating Scale (CARS) (time frame: BASELINE, YEARLY (0-7 YEARS)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.