| CTRI Number |
CTRI/2024/12/077722 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of interventions Gandirikadi tailam and Vajraka kashaya in participants having black thickened skin lesions with itching |
|
Scientific Title of Study
|
Effect of topical application of Gandirikadi tailam along with oral administration of Vajraka kashaya in the management of Kitibha with special reference to Cutaneous Lichen Planus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUKHMI A S |
| Designation |
MD Scholar |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Department of Agadatantra
Govt Ayurveda College Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9400049752 |
| Fax |
|
| Email |
sukhmiabdulkhadar1990@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIJI R S |
| Designation |
Professor and HOD |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Department of Agadatantra
Govt Ayurveda College Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446591947 |
| Fax |
|
| Email |
drshijirs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIJI R S |
| Designation |
Professor and HOD |
| Affiliation |
Govt Ayurveda College Thiruvananthapuram |
| Address |
Department of Agadatantra
Govt Ayurveda College Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446591947 |
| Fax |
|
| Email |
drshijirs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Thiruvananthapuram Kerala India
Pin 695001 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Thiruvananthapuram |
| Address |
Sukhmi A S
Department Of Agadatantra
Govt Ayurveda College Thiruvananthapuram |
| Type of Sponsor |
Other [Govt Ayurveda 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 Sukhmi A S |
Government Ayurveda College Thiruvananthapuram Kera |
Government Ayurveda College Panchakarma Hospital Op no 3
Department of Agadatantra
Poojappura 695012
Thiruvananthapuram
Kerala
Thiruvananthapuram
KERALA |
9400049752
sukhmiabdulkhadar1990@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE(IEC) Govt Ayurveda College Thiruvananthapuram Kerala India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L439||Lichen planus, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: VAJRAKA KASHAYA, Reference: ASHTANGA SANGRAHAM, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -N/A | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: GANDIRIKADI TAILAM, Reference: CAKRADATTAM, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -N/A |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants presenting with symptoms of Cutaneous lichen planus – erythema / discolouration, hypertrophy, scaling, hyperpigmentation, scarring atrophy and also pruritis
2.Both male and female participants with age limit between 25-65 years
|
|
| ExclusionCriteria |
| Details |
1. Participants with uncontrolled systemic illness - hypertension, diabetes mellitus, thyroid dysfunction.
2. Pregnant women and lactating mothers.
3. Participants under steroidal medication
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the assessment parameters – erythema / discolouration, hypertrophy, scaling, hyperpigmentation, scarring atrophy, pruritis. |
0 th day
15 th day
31 st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3 |
|
Date of First Enrollment (India)
|
17/12/2024 |
| 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="6"
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
|
Skin diseases are the most common health problems worldwide and are caused by social, physical and psychological factors which leads to the impairment in quality of life. Steroids are the drug of choice for cutaneous lichen planus and on prolonged use it produces various local and systemic side effects ranging from mild to severe. Thus an effective treatment is the need of hour |