| CTRI Number |
CTRI/2022/02/040085 [Registered on: 07/02/2022] Trial Registered Prospectively |
| Last Modified On: |
30/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of khadir compound in the management of Kitibha (psoriasis) |
|
Scientific Title of Study
|
Comparative clinical and biochemical evaluation of khadir(Acacia catechu) compound in the management of kitibha(psoriasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gouri Chauhan |
| Designation |
PhD scholar |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Kayachikitsa faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi.
Sir Sunderlal Hospital,Ayurveda wing,Kayachikitsa OPD no 21 and 22, Department of Kayachikitsa, Faculty of Ayurveda, Institute of Medical Sciences,BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9555567218 |
| Fax |
|
| Email |
gourimedico@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr O P Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Kayachikitsa faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi.
Sir sunderlal hospital, Ayurveda wing, Kayachikitsa OPD, Room number 21 and 22,Department of Kayachikitsa,
faculty of Ayurveda, Institute of Medical sciences BHU.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr O P Singh |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Kayachikitsa faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi.
Sir Sunderlal Hospital, Ayurveda wing, Kaychikitsa OPD no. 21 and 22, Department of kayachikitsa, faculty of Ayurveda, Institute of Medical Sciences, BHU,
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415818732 |
| Fax |
|
| Email |
singhopbhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda Institute of Medical Sciences BHU Varanasi |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences |
| Address |
IMS BHU Varanasi |
| 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 OP Singh |
Sir Sunderlal Hospital BHU |
OPD no. 21 and 22, Indian Medicine Wing Department of kayachikitsa Faculty of Ayurveda IMS BHU
Varanasi
UTTAR PRADESH |
9415818732
gourimedico@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee IMS BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: Kitibha Psoriasis, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Khadir daruharidra nimb, Reference: Astang Hridaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: Shaman chikitsa | | 2 | Comparator Arm (Non Ayurveda) | | - | Methotrexate | It inhibit DNA synthesis of epidermal cells thus preventing epidermal cell hyperplasia. | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Khadir, Reference: Astang Hridaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: Shaman chikitsa | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Daruharidra, Reference: Astang Hridaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water ), Additional Information: Shaman chikitsa | | 5 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nimb, Reference: Astang Hridaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Water), Additional Information: Shaman chikitsa |
|
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed as psoriasis. 2. Age from 17 to 70 years. 3. Patient willing to participate in the research and voluntarily give written consent. |
|
| ExclusionCriteria |
| Details |
1. Age less than 17 years and more than 70 years. 2. Pregnant and lactating mothers 3. Patient receiving panchakarma therapy or other conventional medicine.4. Psoriatic complications. 5. Patient of liver and kidney disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. CBC 2. ESR 3. TNF alpha, 4. CRP 5. Cytokines. |
At initial visit of patient and repeated after 3 months of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate the clinical effect of Khadir. 2. To evaluate the clinical effect of daruharidra. 3. To evaluate the clinical effect of nimb. 4 to evaluate the clinical effect of khadir, daruharidra and nimb in combination. 5. To evaluate the cell line study of khadir, daruharidra and nimb. Assessment scales are PASI score, IGA scale, Itching, Scaling, Erythema, Dryness, Roughness, Thickness. |
3 months with 3 follow ups of one month each. |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
15/02/2022 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
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 [gourimedico@rediffmail.com].
- For how long will this data be available start date provided 20-02-2022 and end date provided 20-01-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Kitibha (Psoriasis) is a challenging disease with its chronic and relapsing nature. Many herbal and herbomineral preparations are given in the literature and there mechanism of action is also explained on the basis of Ayurvedic terminology. The classical drugs used for treating Kitibha (psoriasis) are needed to be evaluated clinically along with cellular level to understand the probable mode of action of drug in the patient. Also the safety and efficacy of the drug is needed to be evaluated. So keeping in mind these points the study is planned to establish the safe, cost effective, clinically effective shaman chikitsa. |