| CTRI Number |
CTRI/2024/06/068597 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Diagnostic
Preventive
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
efficacy of individualized homoeopathic medicine in patients of chronic urticaria |
|
Scientific Title of Study
|
An Experimental Study To Ascertain The Effectiveness Of Individualized Homoeopathic
Medicine In Cases Of Chronic Urticaria |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Meeti Gokani |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9429303347 |
| Fax |
|
| Email |
asmandaviya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hitarth Mehta |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarth.mehtarhmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hitarth Mehta |
| Designation |
HOD/ Professor |
| Affiliation |
Rajkot Homoeopathic Medical College, Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarth.mehtarhmc@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road , Rajkot, 360002 |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College Parul University |
| Address |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Meeti Gokani |
Sainath Homoeopathic Hospital, Rajkot Homoeopathic Medical College, Parul University |
Department of Practice of Medicine, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam Chowk, Gondal Road, Rajkot
Rajkot
GUJARAT |
9429303347
asmandaviya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research - Rajkot Homoeopathic Medical College (RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L509||Urticaria, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic
Medicine |
Mode of Administeration - Oral
Route
Selection Of potency Dose and Repetition - Individualized Medicine Will Be Prescribed
In 30, 200, 1m, 10m,Potencies Frequency Of Repetition Will Be Based On Improvement, Susceptibility Of Patients And Principles Of Organon Of Medicine. It Will Be Administered For Period Of 9 Months And Will Be Varied According To The Improvement In Health Of Patient. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age- 15-70 years.
2. Sex- male and female both will be included.
3. Prediagnosed cases of urticaria will
be selected.
4. New cases will be selected on basis of definition of Chronic urticaria.
5. Only those cases which had an onset since 2 months and are not autoimmune in
origin will be taken. |
|
| ExclusionCriteria |
| Details |
1. Age:-less than 15 and more than 70 yrs.
2. Those patients who had/ have any episode of angioedema with urticaria.
3. Patients with chronic urticaria who are on other therapeutic measures.
4. Patients having any other comorbidities.
5. Patients who will not maintain regular follow up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To ascertain effectiveness of Individualized Homoeopathic Medicines in chronic urticaria.
|
it will be achieved within 9 months of period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess improvement in patients of urticaria after administrating homoeopathic medicines
with the help of UAS7 TWICEDAILY ASSESMENT (urticaria activity score). |
it will be achieved within 9 months of period |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [asmandaviya@gmail.com].
- For how long will this data be available start date provided 17-06-2024 and end date provided 17-06-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
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.â€
Medicines are selected on basis of symptom similarity in each suffering individual. It when
taken reduces hypersensitivity to allergen and reduces dependency on antihistamine. |