| CTRI Number |
CTRI/2024/02/063314 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Autologous Serum Therapy versus Histaglobulin in management of Chronic Idiopathic Urticaria |
|
Scientific Title of Study
|
Comparative Evaluation of Therapeutic Efficacy of Autologous Serum Therapy versus Injection Histaglobulin in Chronic Idiopathic Urticaria: An Open-label Randomized Control Trial |
| 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 Sushantika |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Dermatology, AIIMS, Rishikesh
Room- 709, Building- 85,AIIMS, Rishikesh Campus
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9026564805 |
| Fax |
|
| Email |
sushantika1992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushantika |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Dermatology, AIIMS, Rishikesh
Room- 709, Building- 85,AIIMS, Rishikesh Campus
UTTARANCHAL
249203
India |
| Phone |
9026564805 |
| Fax |
|
| Email |
sushantika1992@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushantika |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, Rishikesh |
| Address |
Department of Dermatology, AIIMS, Rishikesh
Room- 709, Building- 85,AIIMS, Rishikesh Campus
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9026564805 |
| Fax |
|
| Email |
sushantika1992@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Rishikesh, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
AIIMS, Rishikesh |
| Address |
AIIMS, Rishikesh, Uttarakhand |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sushantika |
All India Institute of Medical Sciences, Rishikesh |
Department og Dermatology, AIIMS, Rishikesh
Room no-033110, Second floor, OPD Block
Dehradun
UTTARANCHAL |
9026564805
sushantika1992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Idiopathic Urticaria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autologous serum therapy |
In one group , 2ml of the fresh serum separated from the patient’s blood is given deep Intramuscular(IM) for 10 successive weeks.
After 12 weeks post therapy, we compare the efficacy in both groups |
| Intervention |
Injection Histaglobulin |
1‑ml subcutaneous injection of histaglobulin which is a combination of human normal immunoglobulin (12 mg) and histamine dihydrochloride (0.15 mcg) is given for 10 weeks.
After 12 weeks post therapy, we have to compare the efficacy in control of chronic urticaria between comparator and intervention group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
18 years or above patient willing to give consent and not having any contraindication for the procedure |
|
| ExclusionCriteria |
| Details |
Active microbial infection,
Pregnancy or Lactation, Hypersensitivity to Histaglob injection, Immunosuppressed cases or uncontrolled Diabetes mellitus |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the therapeutic efficacy of AST and injection Histaglobulin in patients of chronic idiopathic urticaria on the basis of change in Urticaria Activity Score and Dermatology Life Quality Index from baseline after 12 weeks post completion of either modality. |
At baseline, then at 10 weeks and after 12 weeks from the point of last injection given in either group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the reduction of antihistamine usage by patient on either of these modalities of therapy for chronic urticaria. |
One year duration |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
The recruitment will start after CTRI registration. Only patients of Indian ethnicity visiting Dermatology OPD AIIMS, Rishikesh for management of chronic urticaria who are willing to give consent for the study will be recruited . |