Submitting a Monograph

Guidelines for Homeopathic Drug Provings

Approved April 2015

Glossary

Adverse Event – Within the context of a Proving, an adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a proving. It may be a new illness, worsening of a concomitant illness, an injury, or any concomitant impairment of a subject’s health (including symptoms and observed clinical effects) that is unexpected and clinically significant.

Characteristic Symptom (see under “Symptom”)

Clinical Coordinator – personnel who typically coordinate subject enrollment, collection of data, control of protected health information, and other non-clinical aspects of the Proving.

Concomitant Symptom (see under “Symptom”)

Control – Placebo or physiologically inert compound that is indistinguishable from verum or active medication used in a Proving and is not expected to cause any significant mental, physical or emotional reactions in subjects due on the basis of its physical/biological properties.

Environmental Factors – include any external influence upon the body / mind such as temperature, food, emotional influence, trauma, time of day, etc.

Ethics or Institutional Review Board (IRB) – is an Institution based review board as defined in U.S. federal regulation 45CFR46.102.

Existing Symptom (see under “Symptom”)

Homeopathic Interview – specific techniques for gathering both subjective and objective data gathered according to homeopathic principles which focus upon understanding the individual’s dynamic, homeostatic balance in response to various internal and external stressors.

Homeopathic Medicinal Product – Any medicinal product prepared from products, substances or compositions called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the HPUS and/or European Pharmacopoeia or, in absence thereof, by an officially recognized national pharmacopoeia.

Investigational Proving Substance (IPS) – A homeopathic medicinal product that is being evaluated through a proving for submission as a monograph to the HPCUS. The term IPS is used to refer to both the actual verum substance being proved, and the combination of verum and control forms allocated to the test subjects during the trial according to the context of use of the term within the guidelines.

Modality – An environmental or other factor related to a symptom that is associated with either increasing or decreasing the duration, severity, or frequency of that symptom ⁽²⁴⁾.

New Symptom (see under “Symptom”)

Objective Data – includes any information that is obtained through observation, physical or psychological examination, or testing of subjects using an external observer. Testing may include laboratory studies, radiologic tests, psychological or other instruments, weight measures, or any other biomarker measurement.

Past Symptom (see under “Symptom”)

Peculiar Symptom (see under “Symptom”)

Principal Investigator – An individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. The principal investigator will review and sign-off the final report.

Project Coordinator – reports directly to the principal investigator and is primarily responsible for facilitation and coordination of the clinical trial activities including financial, personnel, communication, or other related administrative duties.

Protected Health Information – individually identifiable health information, held or maintained by a covered entity or its business associates acting for the covered entity that is transmitted or maintained in any form or medium (including the individually identifiable health information of non-U.S. citizens). This includes identifiable demographic and other information relating to the past, present, or future physical or mental health or condition of an individual, or the provision or payment of health care to an individual that is created or received by a health care provider, health plan, employer, or health care clearinghouse. For purposes of the Privacy Rule, genetic information is considered to be health information.

Proving Supervisor –personnel (generally with homeopathic training) who may evaluate subjects oversee subject response to investigational medicinal product administration, clarify subjective responses, and record observable data during the Proving.

Proving Symptom (see under “Symptom”)

Randomized Controlled Trials – are studies that randomly assign individuals to an intervention group or to a control group, in order to measure the effects of the intervention.

Reasonable Possibility – Within the context of provings, the causality of adverse events by the IPS is a reasonable possibility when the presence of facts or evidence or arguments suggests a causal relationship.

Serious Adverse Reaction – Within the context of provings, an adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Suspected Adverse Reaction – Within the context of Provings is defined as any adverse event for which there is a reasonable possibility that the IPS caused the adverse event.

Suspected Unexpected Serious Adverse Reaction – An adverse event or suspected adverse reaction is considered “unexpected” if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. The event is considered a suspected serious adverse reaction if there is cause to suspect a relation to the investigational Proving Substance (IPS) administration and the event, and the severity would make the event a Serious Adverse Event.

Symptom – Any change in the normal objective as well as subjective state of mind or body, as experienced by the subject, or as observed by the practitioner and/or others. (Adapted from Swayne et al) ⁽²⁵⁾

• Characteristic Symptom – Symptom produced in a Proving subject which has a higher probability of being related to the IPS, and may include strong, peculiar, or highly individualistic symptoms as well as those symptoms which are strongly aggravated or ameliorated during the Proving. Additional parameters are listed in Section 7.
• Concomitant Symptom – Symptom associated with other symptoms in different parts of the body, or the mind, that appears at the same time or during the same disease process, e.g. a headache that occurs during diarrhea, or anxiety that occurs with stomach pain, etc.
• Existing Symptom – Symptom reported by subject or noted by the supervisor that was previously experienced or is experienced by the subject in an ongoing manner prior to IPS administration within the recent past and could be expected to occur during the Proving period. Note: such symptoms are often referred to as “Old” symptoms in the homeopathic Proving literature.
• Highly Characteristic Symptom – any symptom in a proving subject during the test period that is sufficiently individualizing to allow a clinician to reasonably consider the use of the medicine based upon that clinical feature alone. Additional parameters are listed in Section 7.
• New Symptom – Symptom reported by subject or noted by the supervisor that was not previously experienced by the subject prior to IPS administration.
• Past Symptom – Symptom reported by the subject to have occurred prior to the IPS administration that was resolved and would not be expected to recur during the Proving time period.
• Peculiar Symptom – also referred to as a Strange, Rare or Peculiar Symptom. This is a symptom which is highly individual because it is uncommon, surprising (e.g. paradoxical), or unusual in itself (e.g. a small child craving hot curry), idiosyncratic, or strikingly uncharacteristic of the complaint (e.g. a painless wound).
• Proving Symptom – Symptom or sign occurring during the Proving period which is possibly related to the IPS. Symptoms that occur in a severity, duration and frequency consistent with historical tendency, or can confidently be attributed to a cause external to the Proving should NOT be reported as a Proving symptom.
• Unexpected – Symptom or sign occurring during the Proving period that is not consistent with investigational product information. For the purposes of provings, unexpected symptoms include any symptoms or signs that have duration longer than the proving period, have clinical severity greater than described in the Informed Consent, have clinical severity that falls within the definition of Serious Adverse Event, require therapeutic intervention, or result in removal from the Proving.

Therapeutic Intervention – Medical or other treatment deemed medically necessary by the Supervisor for a subject during the course of a Proving other than the IPS or treatment that was ongoing prior to Proving initiation.

Verum – Active Medication that is used in a research trial, as opposed to the placebo or control substance.

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(1) Jay Yasgur. Homeopathic Dictionary and Holistic Health Reference. 2007.

(2) Swayne J eds. Churchill Livingstone’s International Dictionary of Homeopathy. London: Churchill Livingstone, 2000.