| CTRI Number |
CTRI/2022/10/046834 [Registered on: 27/10/2022] Trial Registered Prospectively |
| Last Modified On: |
25/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two drugs saptaparna bark and chirabilva bark in patients with Kitibha kushta (psoriasis) |
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Scientific Title of Study
|
A COMPARATIVE CLINICAL EVALUATION OF EFFICACY OF SAPTAPARNA (ALSTONIA SCHOLARIS.R.Br.) BARK AND CHIRABILVA (HOLOPTELIA INTEGRIFOLIA ROXB.PLANCH.) BARK FOR KUSTHAGHNA KARMA VIS-A-VIS TO KITIBHA KUSHTA (PSORIASIS)
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinoda Y Sidaraddi |
| Designation |
2nd year Pg Scholar Dravyaguna Department |
| Affiliation |
Government Ayurveda medical college Dhanvantari road Bangalore 560009 |
| Address |
Government Ayurveda medical college Dhanvantari road Bangalore 560009
Government Ayurveda medical college Dhanvantari road Bangalore 560009
Bangalore
KARNATAKA
560009
India |
| Phone |
8867839367 |
| Fax |
|
| Email |
vinodasidaraddi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha Sri S |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda medical college Bangalore |
| Address |
Department of pg studies in Dravyaguna
Government Ayurveda medical college Bangalore
Government Ayurveda medical college Dhanvantari road Bangalore 560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9886010633 |
| Fax |
|
| Email |
mamathasri.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mamatha Sri S |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda medical college Bangalore |
| Address |
Department of pg studies in Dravyaguna
Government Ayurveda medical college Bangalore
Government Ayurveda medical college Dhanvantari road Bangalore 560009
Bangalore
KARNATAKA
560009
India |
| Phone |
9886010633 |
| Fax |
|
| Email |
mamathasri.ayu@gmail.com |
|
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Source of Monetary or Material Support
|
| Government Ayurveda medical college and hospital Bengaluru 560009 |
|
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Primary Sponsor
|
| Name |
Dr.Vinoda Y Sidaraddi |
| Address |
Government Ayurveda medical college Dhanvantari road Bangalore 560009 |
| Type of Sponsor |
Other [Self ] |
|
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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 Vinoda Y Sidaraddi |
Government Ayurveda medical college and hospital Bengaluru |
Government Ayurveda medical college and hospital dhanwantari road Bangalore 560009
Bangalore
KARNATAKA |
8867839367
vinodasidaraddi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee of Government Ayurveda medical college Bangalore |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KITIBAH, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saptaparna kashaya, Reference: Bhavaprakash nighantu vatadivarga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water ), Additional Information: -extrnally saptaparna taila two times a day | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chirabilva twak kashaya, Reference: Bhavaprakash nighantu guduchyadi varga , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -warm water ), Additional Information: -extrnally Chirabilva twak taila two times a day |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are willing to be a part of research work.
Subjects with chronicity not more than 2yrs.
Subjects with mild to moderate disease.
|
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| ExclusionCriteria |
| Details |
1.subjects with Kitibha kushta having extracutaneous manifestations.
2.subjects with other systematic disorders like DM,HTN,Asthama.
3.pregnant women and lactating mothers.
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Classical symptoms of Kitibha kushta |
Before treatment -on 0th day
During fallow up -on every 15th days
After treatment -on 30th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Candle grease sign
Auspitz sign
PASI scoring |
Before treatment -on 0th day
During fallow up -on every 15th days
After treatment -on 30th day |
|
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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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2022 |
| 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="1"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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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
|
This study is a randomised open labeled comparative parallel group clinical trial.It involves comparing the efficacy of Saptaparna twak kashaya internally 48ml twice a day before food and saptaparna twak tail external application twice a day for 30 days with that of chirabilva twak kashaya and tail. In this study classical symptoms of Kitibha kushta, candle grease sign, auspitz sign and PASI scoring will be assessed on before treatment, during fallow up and after treatment. |