An Open-Label Study to Assess the Efficacy of Teucrium marum verum in Treating Pinworm Infestation among Pediatric Patients.

SYNOPSIS

 OF

 AN OPEN-LABEL PILOT STUDY TO ASSESS THE EFFICACY

OF TEUCRIUM MARUM VERUM IN TREATING PINWORM

INFESTATION AMONG PEDIATRIC PATIENTS

 By

SHREYA SHEE, 3rd BHMS Student

Under the guidance of

DR. EHTESHAM KHAN**,**M.D. (HOM.)

Asst. Professor, Department of Organon of Medicine

METROPOLITAN HOMOEOPATHIC MEDICAL

COLLEGE AND HOSPITAL (MHMCH),SODEPUR RAMCHANDRAPUR

KOLKATA-700110, WEST BENGAL

 

1. NAME OF THE CANDIDATE:         SHREYA SHEE

 2.PERMANENT ADDRESS:                 92 GREENPARK, NARENDRAPUR

KOLKATA-700103

 3. NAME OF THE INSTITUTION:       METROPOLITAN MEDICAL COLLEGE AND

HOSPITAL(MHMCH)

 4. SESSION:                                            2020-2025

 5. TITLE OF THE TOPIC:                     AN OPEN-LABEL PILOT STUDY TO

ASSESS THE EFFICACY OF TEUCRIUM

MARUM VERUM  IN TREATING PINWORM

INFESTATION AMONG PEDIATRIC PATIENTS

        INTRODUCTION:

Intestinal parasitic infections continue to be the most common diseases affecting children from low and middle-income countries and is the greatest single worldwide cause of illness and disease1. In India, the prevalence rate of worm infestation as per data from 127 surveys is over 20%2.The present study covers the commonly prevalent intestinal nematode of public health importance3which is the pinworm(Enterobius vermicularis)4,5.  Poverty, overcrowding, warm climate, open defecation, vulnerable water supply and poor food hygiene are main factors underpinning parasitic burden in children6.

At highest risk of morbidity are pre-school and school-aged children7. Negative effects of

helminth infections include diminished physical fitness and growth retardation, and delayed

intellectual development and cognition. It is linked with an increased risk for nutritional anemias,protein-energy malnutrition with further recurrency. Therefore, the present study is chosen to study the role of Teucrium marum verum in the treatment of pinworm infestation8.

 Teucrium marum verum is derived from the plant commonly called cat-thyme from family labiatae.This entirefresh plant is used for the preparation of medicine. The major symptoms of Teucrium marum verum include itching in the anus and constant irritation in the evening in bed, crawling sensationin the rectum after stool, restless sleep with twitching as reported in the homoeopathic literature9,10. Moreover the site of study is located in an area constituting adumping ground with people belonging to the lower economic classes. Hence, I think it is theright time to evaluate the scope of Teucrium marum verum in this highly burden disease ofchildhood.

 RESEARCH QUESTION:

Whether Teucrium marum verum has a significant role in pinworm infestation of pediatric age group.

 HYPOTHESIS:

**Null hypothesis:**Teucrium marum verum has no significant role in treatment of worm

infestation.

**Alternative hypothesis:**Teucrium marum verum has significant role in the treatment of worminfestation.

 BACKGROUND AND JUSTIFICATION OF STUDY:

A pilot study serves as a preliminary investigation designed to gather information, test the feasibility of a larger study, and refine research techniques.Assessing the efficacy of Teucrium marum verum (also known as Cat Thyme or Cat Thyme Germander) in pinworm infestation through a research study requires a solid background and justification. Here are key points to consider:

Background:

Globally more than two million people are affected by pinworms, especially the children2.

It can cause discomfort, itching and may lead to complications if not treated properly.

In recent times pinworm infestation treatment involves conventional pharmaceuticals but it may include resistance and side effects. This leads to explore alternative or complementary treatments.

   Examining Teucriummarum verum’s potential for treating pinworm infestation is in line with the pursuit of investigating conventional treatments for modern medical conditions.

Teucrium marum verum has a phytochemical11 composition that includes terpenoids and essential oils. Knowing the chemical makeup of the plant might help identify probable processes of its action. There are not much scientific study on Teucrium marum verum’s effectiveness in treating pinworm infestation, despite its traditional use. An investigation can aid in bridging this gap.

Justification for the Study:

Given the challenges and limitations associated with conventional treatments, exploring alternative therapies, with Teucrium marum verum, can offer a broader range of options for managing pinworm infestation.

The evaluation of Teucrium marum verum’s safety and tolerability is of utmost importance. A research study can keep an eye on side effects and assist in determining the right dosage ranges for possible usage.

Traditional use can serve as a starting point, but scientific validation via a carefully planned study lends credence to Teucrium marum verum’s possible effectiveness in treating pinworm infestation.A pilot research makes it possible to keep an eye out for any negative effects and guarantee that participants are using Teucrium marum verum in a safe manner.

Research protocols can be improved for a wider, more thorough examination by taking into account preliminary results from a pilot study.

Pinworm infestation outcomes may vary among individuals. A pilot study helps understand this variability, enabling better estimation of sample size for a larger study.

Exploring homoeopathic remedies aligns with a patient-centered approach, acknowledging individual preferences and the growing interest in natural or plant-based treatments.

If Teucrium marum verum proves effective, it could have significant public health implications, especially if it offers a safe and accessible alternative for pinworm treatment.

 In conclusion, a pilot study assessing the efficacy of Teucrium in pinworm infestation is justified to address gaps in current knowledge, evaluate feasibility, and refine research methods before embarking on a larger, more comprehensive investigation ensuring ethical considerations and participant safety in the planning and execution of such studies.

 AIMS & OBJECTIVES:

**Primary objective:**To assess the efficacy of Teucrium marum verum in treatment of pinworm in pediatric patients.

 Secondary objective:

To list down the clinical symptoms of Teucrium marum verum whatevermaybe observed during the course of study.

 REVIEW OF LITERATURE:

Studies were conducted on Teucrium and its effectiveness pertaining to various aspects like nasal polyps associated with rhinosinusitis12, gout13 and chemical nature accosting to anitimicrobial and antioxidant activity14.

A general overview of the available information found are listed:

 Teucrium marum verum contains phytochemicals11such as essential oils and terpenoids. These compounds may contribute to its potential medicinal properties.

There are no human studies conducted, particularly clinical trials, that address Teucrium marum verum for the potential treatment of pinworm infestation. Thorough clinical trials are necessary to prove its efficacy and safety in people.When thinking about using herbal medicines, it is important to comprehend the safety concerns.

The literature may point out information gaps and difficulties in the field of studying herbal treatments for pinworm infestation, for Teucrium marum verum. Finding these gaps can help direct the course of future study.

The various symptoms of Teucrium marum velum are listed in the books by our great stalwarts which will be taken as source of reference9,10.

 METHODOLOGY:

**TYPE OF STUDY AND STUDY DESIGN:**Open label prospective pilot study.

 STUDY****POPULATION:

**(a) Study site:**Metropolitan Homoeopathic Medical College and Hospital

**(b) Study setting:**Outdoor patient department (O.P.D) Indoor patient department(I.P.D)

 **SAMPLE SIZE:**Being a pilot study, a sample size of minimum 36 patients for the 6 months of treatment period for each individual will be considered.

 SELECTION CRITERIA:

Inclusion criteria:

❖Pediatric patients of both sexes upto 18 years15.

❖Patients showing clinical features of worm infestation.

❖ Patients with a scoring greater than or equal to 1 of 5-D pruritis scale16 and or GRS(Graphic Rating Scale) for abdominal pain17.

❖Patients with positive NIH swab4 report.

Exclusion criteria:

❖Patients coming with complains other than worm infestation.

❖Patients clinical evidences of acute condition or life threatening diseases.

❖Patients taking any medicines of homoeopathic or other systems.

 INTERVENTION:

With patients included as per selection criteria, NIH swab test will be done.

Moreover scores of 5-D pruritis scale16 and GRS of abdominal pain17 will be recorded.

 NIH swab method as devised in National Institute of Health, USA4:

 Â·      It consists of a glass rod attached to a cellophane tape by a rubber band.

·      The other end of the glass rod is fixed by a rubber stopper and kept in a test tube.

·      The cellophane part of the glass rod is rolled over the perineal and perianal skin area to collect the sample.

·      After the tape is transferred to a slide, microscopic examination will detect Enterobius eggs, which are planoconvex, flattened along one side containing a larva inside.

 Teucrium marum verum of 30 centesimal potency in liquid whichever will be suitable will be administered among the patients along with a proper follow up within a period of 3 months. On every follow ups scoring will be analysed and NIH swab test report to be considered at the entry and end of treatment for results.

 SELECTION OF TOOLS:

❖NIH swab4 test report of perianal region.

❖5-D pruritis scale16 and Graphic Rating Scale(GRS) for abdominal pain17.

❖Severity of the patients’ illness, before and after treatment, shall be assessed on Clinical

global Impression – Severity scale(CGI-S).

❖Patients improvement after treatment shall be assessed on Clinical global impression-

Improvement scale(CGI-I scale).

❖Patients’ general sense of well-being shall be assessed on Quality of Life Scale (QOL

scale).

 BRIEF OF PROCEDURES:

**STEP 1:**The study will be conducted among 36 patients as per pilot study. Proper case taking of the patient as per strict homoeopathic principle19 will be done.

**STEP 2:**Patients satisfying inclusion and exclusion criteria will be included along with informed consent and assent wherever required.

**STEP 3:**Teucrium marum verum will be prescribed in 30 centesimal potency maintaining strict homoeopathic principles.

**STEP 4:**Proper follow up for a minimum 6 months will be done.

**STEP 5:**Results will be analysed and interpreted after the completion of study by using appropriate statistical methods.

 DATA COLLECTION:

❖Case Recording One standard case recording format of Metropolitan Homoeopathic Medical College & Hospital will be taken.

 â–Selection of medicine: Similar symptoms of Teucrium marum verum given by the patient

suffering from pinworm infestations, Teucrium will be administered in potentized form.

 â–Selection of Potency : 30 centesimal potency will be given by strict Homoeopathic criteria.

 â–Follow up: After administering Teucrium marum verum and offering instructions, patients willbe scheduled for monthly follow-up appointments over a 3-month period. During each visit, detailed records will be maintained to track improvements or deterioration of their condition.

 â–Assessment of results: Patients’ outcome shall be assessed as per the NIH swab test report and scoring of 5-D pruritis scale, GRS for abdominal pain, scoring of CGI-S, CGI-I and QOLwith general improvement/ worsening in the given case.

 â–Administration of medicines: The medicine will be applied through oral route as per protocol.

 OUTCOME ASSESSMENT:

**Primary outcome:**It will be based on the scoring of 5-D16 pruritis scale, GRS17 for abdominal pain, CGI-S, CGI-I and QOL.

 **Secondary outcome:**Patients’ outcome shall be assessed as per the NIH swab4 test report at entry and end of the treatment.

 **QUALITY CONTROL:**Medicines will be procured from GMP certified company.

 **CONFIDENTIALITY:**Patient’s’ information will not be disclosed.

 STATISTICAL TECHNIQUES AND DATA ANALYSIS: After completion of the study the result

will be represented by using different statistical methods, such as Chai-square, t-test, and Pearson correlation for analysis of the result.

 **ETHICAL CONSIDERATION:**The research proposal entitled “An Open-Label Pilot Study to Assess the Efficacy of Teucrium marum verum in treating pinworm infestation among Pediatric patients” has to undergo the IEC clearance before initiation of the actual work.

 **IMPLICATION:**This open-label pilot study holds the potential to shed light on the preliminaryefficacy of Teucrium marum verum in treating pinworm infestation among pediatricpatients. The findings will inform future research design and contribute to addressing thissignificant health challenge. By evaluating both symptom improvement and stool examinationoutcomes, the study aims to contribute to the understanding of homoeopathic interventions for pediatric worm infestations.

 REFERENCES:

1. Bharti B, Bharti S, Khurana S, Pandhi BS. Worm infestation: diagnosis, treatment and

prevention. Indian J Pediatr. 2017 Sep;84(9):704-707.

 2. World Health Organization. Soil-transmitted helminthiases: eliminating soil-transmitted

helminthiases as a public health problem in children: progress report 2001–2010 and strategic

plan 2011–2020. Geneva: World Health Organization; 2012.

 3. Kumar H, Jain K, Jain R. A study of prevalence of intestinal worm infestation and efficacy of anthelminthic drugs. Med J ArmedForces India. 2014 Apr;70(2):144-148.

 4. Sastry AS, Bhat SK. Essentials of medical parasitology. 1st ed. 2014. p. 224-246.

  5. Chatterjee KD. Parasitology in relation to clinical medicine. 13th ed. Chaterjee Medical

Publishers; 1998. p. 205-235.

 6. Brooker S, Clements AC, Bundy DA. Global epidemiology, ecology and control of

soiltransmitted helminth infections. Parasitology. 2006;62:221-261.

 7. World Health Organization (WHO). Helminth control in school-age children: a guide for

managers of control programmes. 2nd ed. 2011.

 8. Lahane DS. To study the efficacy of Cina Maritima in the management of worm infestation.Int J Res Publ Rev. 2023 Mar;4(3):4032-4036.

 9. Boericke W. New manual of homoeopathic materia medica with repertory. 48th ed. B. Jain Publishers; 2021. p. 561.

 10. Murphy R. Lotus materia medica. 2nd rev ed. B. Jain Publishers; p. 1751-53.

 11. Bianco A, Ramunno A,Serafini M.Phytochemical characters of teucrium marum from Sardinia: an endemic plant Published in Natural Product Research 1 December 2004 Chemistry, Environmental Science, Medicine

 12. Bhattacharjee B, Dutta A. Homoeopathic Medicine Teucrium marum varum in Treatment of Nasal Polyps Associated with Chronic Rhinosinusitis: A Case Report

Homœopathic Links 2022; 35(03): 198-204.

 13. Maher P.The Kaleidoscope of Plant Prescriptions: A Case of Teucrium Marum

Homœopathic Links 2017; 30(02): 097-100.

 14. Ricci D, Fraternale D, Giamperi L, Bucchini A, Epifano F, Burini G, Curini M.Chemical composition, antimicrobial and antioxidant activity of the essential oil of Teucrium marum (Lamiaceae)Journal of Ethnopharmacology, Volume 98, Issue 1-2, 8 April 2005, Pages 195-200.

 15. IAP Policy on Age of Children for Pediatric Care.Indian Pediatrics 1999; 36:461-463 [Internet]. Available from: https://www.indianpediatrics.net/

 16. The 5‐D itch scale: a new measure of pruritus The 5‐D itch scale: a new measure of pruritus Elman S, Hynan LS, Gabriel V,Mayo MJ,British Journal of Dermatology, Volume 162, Issue 3, 1 March 2010, Pages 587–593.               17. H. Mathias, E. Achim; Pain assessment; 2006 Jan; 15(Suppl 1): S17–S24.