| CTRI Number |
CTRI/2025/05/086352 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Sequential treatment plan using Bakuchi seeds for Eczema |
|
Scientific Title of Study
|
Development of an Algorithm for Bakuchi Beeja
(Psoralea corylifolia Linn.) in the management of Eczema through Clinical Assessment
|
| 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 Rujuta Joshi |
| Designation |
MD scholar |
| Affiliation |
Government Ayurveda College Vadodara |
| Address |
Government Ayurved College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019
Vadodara
GUJARAT
390019
India |
| Phone |
7744819735 |
| Fax |
|
| Email |
rujuta12j@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip K Jani |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College,Vadodara |
| Address |
Government Ayurved College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigisha Patel |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda College,Vadodara |
| Address |
Government Ayurved College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019
Vadodara
GUJARAT
390019
India |
| Phone |
9228874121 |
| Fax |
|
| Email |
Jigishaamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College and Hospital |
| Address |
Government Ayurved College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 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 |
| DrRujuta Joshi |
Government Ayurveda College and Hospital,Vadodara |
OPD No.19 and IPD,Upgraded Department of Dravyaguna,Government Ayurved College and Hospital, Outside Panigate, Opp. Panigate Depot, Vadodara, Gujarat 390019
Vadodara
GUJARAT |
7744819735
rujuta12j@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurved college and Hospital, Vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak chikitsa 7, Procedure details: Deepan & Pachan- 3 to 5 days, BD
Snehapana- Go ghrita- 3 to 5 days,OD
Abhyanga with Tila Taila - 3 days
Swedana-3 days
Virechana Karma with Trivritta Avleha
Sansarjan Krama- 3 to 5 days
Shamana Dravya same as comparator arm will be given to this group after the procedure is completed.)
(1) Medicine Name: Trivritta Avleha, Reference: Ashtang Hridaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bakuchi, Reference: Chakradatta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: -Bakuchi Beeja churna with Ardrak swarasa for external application in both the groups |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient who fulfils eczema criteria of American Academy of Dermatology.
Patient having eczema minimum 5 month to maximum 15 year. |
|
| ExclusionCriteria |
| Details |
Patients other than inclusion criteria.
Known case of Disease like D.M, Cancer, AIDS, STD, TB, Renal failure, heart disease and other disorders which lead to fatal condition during Virechana Karma.
Pregnant and lactating women.
Patients with Srava and Paka (For Group-B). |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To develop suitable, accurate and user-friendly Algorithm for Bakuchi Beeja (Psoralea corylifolia Linn.) in the management of Eczema |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To conduct a literary review on Bakuchi (Psoralea corylifolia Linn.) and eczema for clinical applications.
2.To conduct Pharmacognostical and analytical study of Bakuchi Beeja (Psoralea corylifolia Linn.)
3.To conduct a Clinical assessment of two different clinical plans (sequences) of Bakuchi Beeja (Psoralea corylifolia Linn.), in the management of Eczema. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="47" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2025 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This randomized comparative study evaluated Bakuchi Churna in patients of Vicharchika (Shamana alone vs Shodhana followed by Shamana), assessed via POEM, DLQI, and Subjective Lakshana Score. Both groups showed significant within-group improvement on all instruments, with large effect sizes. Against validated MCID thresholds, 100% of patients exceeded the POEM MCID (mean improvement 11.4 points, 3.4× MCID) and 97% exceeded the DLQI MCID (mean improvement 10.3 points, 2.6× MCID), confirming clinically meaningful response. Between-group differences were not significant on the primary POEM endpoint (identical median improvement in both arms), while DLQI and Lakshana score changes showed a medium-effect trend favouring the Shodhana+Shamana group, consistent with the study being underpowered for this comparison. Exploratory analysis linked baseline Kapha Vriddhi to better clinical response and confirmed strong convergence between the subjective Lakshana score and both modern outcome instruments. |