| CTRI Number |
CTRI/2025/02/081255 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
25/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of Twakdoshahara lepa and Karanjadi lepa in combination with Atarushadi Kwatha in Vicharchika (Eczema). |
|
Scientific Title of Study
|
A randomized comaparative clinical study to determine the efficacy of Twakdoshahara lepa and Karanjadi lepa in combination with Atarushadi kwatha 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 Akash M R |
| Designation |
Pg Scholar |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College, Koppa |
| Address |
Department of kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College and Pg center, Koppa 577126, Chikamagalur District
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7259401328 |
| Fax |
|
| Email |
akashmrdravida98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Bhat |
| Designation |
HOD and Professor |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College, Koppa |
| Address |
Department of kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College and Pg center, Koppa 577126, Chikamagalur District
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7619412587 |
| Fax |
|
| Email |
drprashanthbhat@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akash M R |
| Designation |
Pg Scholar |
| Affiliation |
ALN Rao Memorial Ayurvedic Medical College, Koppa |
| Address |
Department of kayachikitsa, 1st floor, ALN Rao Memorial Ayurvedic Medical College and Pg center, Koppa 577126, Chikamagalur District
Chikmagalur
KARNATAKA
577126
India |
| Phone |
7259401328 |
| Fax |
|
| Email |
akashmrdravida98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kayachikitsa OPD, First Floor, ALN Rao Memorial Ayurvedic Hospital, kachkal Road, Koppa, koppa Tq, Chikmagaluru Dist, Karnataka, India. 577126
|
|
|
Primary Sponsor
|
| Name |
Dr Akash M R |
| Address |
Department of Kayachikitsa,1st floor, ALN Rao Memorial Ayurvedic Medical College and PG center, Koppa-577126, Chikmagalur Dist., Karnataka, India. |
| Type of Sponsor |
Private medical 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 Akash M R |
ALN Rao Memorial Ayurvedic Hospital |
Kayachikitsa OPD, Room no 1, First floor, ALN Rao Memorial Ayurvedic Memorial Ayurvedic Hospital, Koppa-577126, Chikmagalur DIST, Karnataka.577126
Chikmagalur
KARNATAKA
Chikmagalur
KARNATAKA |
7259401328
akashmrdravida98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aroor Laxminarayana Rao Memorial Ayurvedic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Charaka Samhitha, Procedure details: Karanjadi Lepa mixed with Gomutra Arka for 20 days)
(1) Medicine Name: Atarushadi Kwatha, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 20 Days | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Rasheshwara Mangala, Procedure details: Twakdoshara lepa mixed with Sarshapa Taila for 20 days)
(1) Medicine Name: Atarushadi Kwatha, Reference: Baishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 20 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects of either sex
2 Subjects within the age group 18 to 60 yrs.
3 Subjects with clinical features of Vicharchika such as Kandu,Pidaka, Syavavarna ,Bahusrava will be included.
4 Subjects with controlled systemic disorder such as DM, HTN etc will be included.
5 Chronicity less than 1 year.
6 Less than grade 3 of EASI score [i.e less than 30 to 49%] will be included in treatment criteria.
7 Subjects must be capable of giving informed consent, willingness and ability to comply with schedule visits,treatment plans and laboratory tests and other study procedures. |
|
| ExclusionCriteria |
| Details |
1 Subjects with infective skin lesions.
2 Subjects with uncontrolled systemic disorder such as DM, HTN etc.
3 Pregnant and Lactating women.
4 Chronicity more than1 year.
5 Subjects of age group less than 18 and more than 60 years.
6 Subjects not willing to give written consent for study.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kandu/Itching
Pidaka/Eruption
Syava varna/Blackish discoloration
Bahu srava/Oozing
|
20 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/03/2025 |
| 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="3"
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
|
This is a single blind randomized comparative clinical study to evaluate the effect of Twakdoshahara lepa and Karanjadi lepa with Atarushadi Kwatha in 20 days. This study comprise of two groups of 30 subjects with kandu (itching), pidaka (eruptions), shayava varna ( blackish discoloration), bahu srava ( oozing) associated with Vicharchika. Study will be conducted in ALN Rao Memorial Ayurvedic Hospital in Koppa, Koppa taluk, Chikamagalur District, Karnataka 577126, India. Primary outcome will be kandu (itcthing), pidaka (eruptions), shayava varna ( blackish discoloration), bahu srava ( oozing) in 20 days |