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Clinical verification of Iberis amara

Clinical verification of Iberis amara: A multicentric prospective interventional single arm clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059533
Enrollment
480
Registered
2023-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J00- Acute nasopharyngitis [common cold] Health Condition 2: R51- Headache Health Condition 3: R14- Flatulence and related conditions Health Condition 4: R197- Diarrhea, unspecified Health Condition 5: R50- Fever of other and unknown origin Health Condition 6: R11- Nausea and vomiting

Interventions

Intervention1: Iberis amara: Iberis amara in 6C, 30C, and 200C homoeopathic dilutions will be prepared at a licensed homoeopathic drugs manufacturer complying with Good Manufacturing Practices (GMP) s

Sponsors

Central Council for Research in Homoeopathy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants presenting with minimum of three signs and symptoms corresponding to the signs and symptoms attributed to the medicines to be verified. 2. Participants presenting with acute or chronic clinical conditions as per the symptomatology mentioned in the ‘Materia Medica’ of the medicines to be verified. 3. Participants who are not taking any homoeopathic medication for their acute presenting complaints. 4. Participants who have not taken any homoeopathic medication for the past one week for their chronic complaints or those who are taking homoeopathic medication but agreeing for a washout period of one week for discontinuing ongoing medications. 5 Participants willing to participate in the study and giving the written informed consent/ assent.

Exclusion criteria

Exclusion criteria: 1. Participants presenting with the clinical presentations other than the symptomatology mentioned in the ‘Materia Medica’ of the medicines to be verified. 2. Participants with history of uncontrolled or life-threatening disease/ systemic illness (tuberculosis, cancer, AIDS, diabetes, hypertension, cardiovascular disorders etc.). 3. Any pre-existing psychiatric disorder. 4. Participants taking concomitant medications like immuno-suppressants, hormonal therapies or other Ayush therapies/ herbal medicines, etc. for chronic ailments. 5. Substance abuse and/or dependence. 6. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
To compare the changes in MYMOP profile scores.Timepoint: At baseline, 3rd, 5th, and 7th day followed by weekly follow-ups for one month in acute conditions. In chronic conditions, it will be compared from baseline and at the end of every 30 days till 06 months.

Secondary

MeasureTime frame
To measure the overall impact on daily life by comparing the ORIDL profile scores.Timepoint: At 3rd, 5th, & 7th day followed by weekly follow-ups for one month in acute conditions. In chronic conditions, it will be compared at the end of every 30 days till 06 months;To compare the causal relationship between homoeopathic intervention & clinical outcome of the medicines to be verified using MONARCH Inventory.Timepoint: At 3rd, 5th, & 7th day followed by weekly follow-ups for one month in acute conditions. In chronic conditions, it will be compared at the end of every 30 days till 06 months;To ascertain clinical symptoms that have been observed after administering the medicines to be verified.Timepoint: At the end of 18 months.;To assess the prevalence of the symptoms in the medicine and remainder population.Timepoint: At the end of 18 months.;To establish prognostic relationship between clinical conditions and symptoms confirmed of the medicines to be verified, expressed as likelihood ratio (LR) of a diagnosis/symptom/characteristic for a specific homoeopathic medicine.Timepoint: At the end of 18 months.

Countries

India

Contacts

Public ContactDr Suhana P Azis

Central Council for Research in Homoeopathy

sui.azis@gmail.com9810554024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026