| CTRI Number |
CTRI/2023/08/056713 [Registered on: 21/08/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development of Precision method for Vicharchika |
|
Scientific Title of Study
|
Development of Precision method and its validation by assessing the effect of Shirisha (Albizia lebbeck Benth.)in Vicharchika |
| 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 Nirali Samajibhai Vekariya |
| Designation |
M.D. Scholar 2nd year |
| Affiliation |
Government Ayurved College, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9512214959 |
| Fax |
|
| Email |
niralivekariya0208@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip K Jani |
| Designation |
H.O.D. and Professor |
| Affiliation |
Government Ayurved College, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Singh |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9510172204 |
| Fax |
|
| Email |
snghsmn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Ajwa road, Dhanvantari marg, Panigate,
Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Goverment Ayurved Hospital, Ajwa road, Dhanvantari marg, Panigate,Vadodara-390019 |
| 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 Nirali Samajibhai Vekariya |
Government Ayurved Hospital, Vadodara |
OPD and IPD,
Dravyaguna
Department
Vadodara
GUJARAT
Vadodara
GUJARAT |
9512214959
niralivekariya0208@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE Government Ayurved College and Hospital Vadodaraa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L259||Unspecified contact dermatitis, unspecified cause. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shirisha, Reference: Dhanvantari Nighantu, Route: Oral, Dosage Form: Lauha-Mandura, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirisha, Reference: Dhanvantari Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirihsha, Reference: Dhanvantari nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shirisha, Reference: Dhanvantari Nighantu, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: Madhu(Honey)), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Symptoms of Vicharchika:
Pidika (Eruption)
Vaivarnya(De-pigmentation)
Kandu(Itching)
Raji (Thickening of skin)
Group A -Vata dominant cases: Rukshata(Dryness/ Roughness)
Group B - Kapha dominant cases: Srava (Discharge) |
|
| ExclusionCriteria |
| Details |
Age Less than 20 and more than 50 years
Uncontrolled DM, HTN,HIV,CKD,Liver cirrhosis,Cardic Failure, Stroke etc.
History of metabolic disorder
Pregnant women and lactating mothers
Group A -Kapha dominant cases: Srava (Discharge)
Group B - Vata dominant cases: Rukshata(Dryness/ Roughness) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in kandu |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| change in Vaivarnya, Pidika, Raji, Rukshta & Srava |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "42"
Final Enrollment numbers achieved (India)="42" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2023 |
| Date of Study Completion (India) |
30/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study has obtained Institutional Ethics committee clearance (GAC/VAD/IEC/76/2023, Date-24/01/2023) and registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/08/056713, [Registered on 21/08/2023]. Study type was open labelled clinical trial. 48 patients were enrolled and divided into four groups (i.e., Group A1-A2 – Vataja Vicharchika, Group B1-B2 – Kaphaja Vicharchika) 12 patients in each group were allocated. Total 42 patients (i.e., 10 patients in group A1, 11 patients in Group A2, 10 patients in group B1, 11 patients in Group B2) were completed the study. All individual four groups A1, A2, B1 and B2 were having significant difference percentage in Vicharchika. In Group A1- Rukshata (50%), Kandu(34%), Pidika (50%) and in Vaivarnya (44%) results were observed. In Group A2- Rukshata (47%), Kandu(51%), Pidika (40%) and in Vaivarnya (43%) results were observed. In Group B1- Srava (70%), Kandu(45%), Pidika (40%) and in Vaivarnya (35%) results were observed. Group B2- Srava (55%), Kandu(51%), Pidika (64%) and in Vaivarnya (41%) results were observed. While, non-significant difference observed between A1-A2 and B1-B2 groups. |