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Clinical Trials/CTRI/2024/06/068597
CTRI/2024/06/068597Not yet recruitingPhase 2

An Experimental Study To Ascertain The Effectiveness Of Individualized Homoeopathic Medicine In Cases Of Chronic Urticaria

Rajkot Homoeopathic Medical College Parul University1 site in 1 country40 target enrollmentStarted: June 17, 2024Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
40
Locations
1
Primary Endpoint
To ascertain effectiveness of Individualized Homoeopathic Medicines in chronic urticaria.

Study Overview

Brief Summary

Chronic urticaria is common in every country globally, and affects 1% of world population of all ages, it’s prevalence has increased to 2-10 fold over last decade .Its prevalence is 4.4% in overall point, out of which 1.5% is in Asia. The mean age of onset is in their late twenties to forties. It is more common at age less than 18 yrs that is about 1.4%. Patients aged more than or equal to 65 years represent prevalence of 10-21.7%.Chronic Urticaria is more common in women up to 80%, but these gender difference is not apparent in children under 15 yrs. Chronic urticaria can occur with angioedema also. Angioedema is reported in approx 40-60% of patients with Chronic urticaria. Chronic Spontaneous urticaria leads to impairment of sleep and cognitive functions and has major impact on social interactions, work performances; daily life functions including inter-personal relationships. Among other skin disorders, Chronic Urticaria is those with highest Health Related Quality Of Life (HRQoL) impairment. Main factors responsible for physical, social, and emotional impact of Chronic Urticaria include the sudden and unpredictable appearance of wheals, angioedema and itch which is very distressing and has major impact on sleep and patients well being. Allopathic treatment for urticaria is antihistamines. But Only 50% patients with Chronic Urticaria have adequate response to antihistamines. Remission rate of Chronic urticaria in adults is 20-75% within 1 year. Resolution rate in children is also very low with studies reporting remission rates in 19% at every year. Homoeopathy focuses on treating man as a whole and not just symptoms of urticaria. It believes in individualization, and law of similia. It does not belief in treating it superficially but treats disease from its root .It offers effective treatment in acute, recurrent and chronic urticaria. As Urticaria is an expression of internal disturbance and hypersensitive reaction reflected on skin. In APH 187 -190 Dr. Hahnemann says “local disease without any external cause is due to some internal disturbance and requires internal malady for their cure.” Medicines are selected on basis of symptom similarity in each suffering individual. It when taken reduces hypersensitivity to allergen and reduces dependency on antihistamine.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
15.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •Age- 15-70 years.
  • •Sex- male and female both will be included.
  • •Prediagnosed cases of urticaria will be selected.
  • •New cases will be selected on basis of definition of Chronic urticaria.
  • •Only those cases which had an onset since 2 months and are not autoimmune in origin will be taken.

Exclusion Criteria

  • •Age:-less than 15 and more than 70 yrs.
  • •Those patients who had/ have any episode of angioedema with urticaria.
  • •Patients with chronic urticaria who are on other therapeutic measures.
  • •Patients having any other comorbidities.
  • •Patients who will not maintain regular follow up.

Outcomes

Primary Outcomes

To ascertain effectiveness of Individualized Homoeopathic Medicines in chronic urticaria.

Time Frame: it will be achieved within 9 months of period

Secondary Outcomes

  • To assess improvement in patients of urticaria after administrating homoeopathic medicines(with the help of UAS7 TWICEDAILY ASSESMENT (urticaria activity score).)

Investigators

Sponsor
Rajkot Homoeopathic Medical College Parul University
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Meeti Gokani

Rajkot Homoeopathic Medical College, Parul University

Study Sites (1)

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