| CTRI Number |
CTRI/2022/07/044297 [Registered on: 25/07/2022] Trial Registered Prospectively |
| Last Modified On: |
18/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
We are comparing the effectiveness of Homoeopathic Medicine(Urtica urens) and Individualized homoepathic medicines in the treatment of hives(Chronic urticaria) |
|
Scientific Title of Study
|
Synopsis on Comparative effectiveness of individualized homoeopathic medicines with urtica urens in cases of chronic urticaria: An open label randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Kanojia |
| Designation |
Post Graduate Trainee |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
National Institute of Homoeopathy, Department of Homoeopathic Materia Medica, OPD No.18, GE-Block, Sector-III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9005699470 |
| Fax |
|
| Email |
abc24995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanta Rath |
| Designation |
Professor, Head Of Department, Community Medicine |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
National Institute of Homoeopathy, Department of Homoeopathic Medica, OPD No. 18, GE-Block, Sector-III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasanta Rath |
| Designation |
Professor, Head Of Department, Community Medicine |
| Affiliation |
National Institute Of Homoeopathy |
| Address |
National Institute of Homoeopathy, Department of Homoeopathic Medica, OPD No.18, GE-Block, Sector-III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
8420924836 |
| Fax |
|
| Email |
drprasantarath09@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Homoeopathy, Block GE, Sector-III, Salt Lake, Kolkata |
|
|
Primary Sponsor
|
| Name |
National Institute Of Homoeopathy |
| Address |
Block GE, Sector-III, Salt Lake, Kolkata- 700106 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Kanojia |
National Institute Of Homoeopathy |
Department of Homoeopathic Materia Medica, Block GE, Sector-III, Salt Lake, Kolkata- 700106
West Bengal
Kolkata
WEST BENGAL |
9005699470
abc24995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L508||Other urticaria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines |
Intervention will be planned as
administering indicated
homoeopathic medicine
selected on the basis of
homoeopathic principles in centesimal potencies. Dose and
frequency depends on the
condition of the patient. All
patients shall be prescribed
homoeopathic medicine after
detailed case taking in
accordance with the direction
laid down by Dr. C. S. F.
Hahnemann in Organon of
medicine. Medicine selection,
potency selection, repetition and
follow up shall be done on the
basis of fundamental guidelines.
the follow-up will be done
monthly till 4 months from the
baseline. |
| Comparator Agent |
Specific Homoeopathic medicine Urtica urens |
Comparator agent will be specific homoeopathic medicine Urtica urens in centesimal or potencies 30,200,1M,10M,and so on. Dose and
frequency depends on the
condition of the patient. All
patients shall be prescibed homoeopathic medicine urtica urens in
accordance with the direction
laid down by Dr. C. S. F.
Hahnemann in Organon of
medicine. Potency selection, repetition and
follow up shall be done on the
basis of fundamental guidelines.
the follow-up will be done
monthly till 4 months from the
baseline. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient of chronic urticaria diagnosed clinically and by blood investigations if necessary
2) Patient of both sexes, all religions and of different socioeconomic status
3) Patient in the age group 15 to 65 years of age 4) Patient able to read and write Bengali/English/Hindi.
5) Patient willing to give written informed consent to participate in the study
6) Patient already undergoing regular conventional treatment for chronic urticaria may be recruited only if the medications are stopped completely 2 weeks prior to the treatment. |
|
| ExclusionCriteria |
| Details |
1) Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled life
threatening illness
2) Substance abuse and/or dependence
3) Severe immune-compromised patients
4) Patients having history of severe anaphylactic shock
5) Pregnant women and lactating mothers. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effectiveness of individualized homoeopathic medicine with empirically selected medicine urtica urens in the management of chronic urticaria using urticaria activity score (UAS7) and chronic urticaria -Quality of life questionnaire (CU-Q2oL.) |
Baseline and after 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Biochemical parameters such as Serum IgE , Complete Blood count, ESR level, etc. |
Baseline and after 4 months |
|
|
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)
|
01/08/2022 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Chronic urticaria is one of the common skin disease we encounter in our day to day clinical practice. Its prevalence is between 0.5 to 1% in the total population with a predominance of females. Homoeopathy plays an important role in treating patient suffering from chronic urticaria. So an open label randomized clinical trial showing the comparative effectiveness of individualized homoeopathic medicine with urtica urens in cases of chronic urticaria will be conducted in National Institute of Homoeopathy, Kolkata. Study has a target to achieve a sample of 40 patients. Primary outcome will be assessed by UAS7(Urticaria activity score) and CU-QoL2(Chronic urticaria quality of life questionnaire) at baseline and after 4 months .Secondary outcome will be assessed by biochemical parameters such as Serum IgE, CBC, ESR ,etc. The score obtained by the patients will be compared and result will be analysed as per appropriate statistical methods and inference will be drawn thereafter. |