| CTRI Number |
CTRI/2025/03/081681 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the guduchyadi kashaya orally with vidangadi lepa external application in comparison with patoladi kashaya internally with vidangadi lepa external application in atopic dermatitis in adults aged 18-60 years for a period of 30 days |
|
Scientific Title of Study
|
To study the efficacy of guduchyadi kashaya with vidangadi lepa in comparison with patoladi kashaya with vidangadi lepa in vicharchika atopic dermatitis :A controlled randomized clinical study |
| 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 Prashanth S U |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital , Bangalore |
| Address |
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka,
India
Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
09148774489 |
| Fax |
|
| Email |
prashanthsuprashanthsu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Sharma M |
| Designation |
Associate Professor |
| Affiliation |
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital , Bangalore |
| Address |
Dept of Kayachikitsa OPD No-1 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka,
India
Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9964022654 |
| Fax |
|
| Email |
drsharmamysr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth S U |
| Designation |
Post Graduate Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital , Bangalore |
| Address |
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka,
India
Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
09148774489 |
| Fax |
|
| Email |
prashanthsuprashanthsu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka,
India
Bangalore
|
|
|
Primary Sponsor
|
| Name |
Dr Prashanth S U |
| Address |
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka,
India
Bangalore
|
| Type of Sponsor |
Other [[self ]] |
|
|
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 Prashanth S U |
SDM Institute of Ayurveda and Hospital |
Dept of Kayachikitsa OPD No.1,2,3,18,27 Shri Dharmasthala
Manjunatheshwara Institute of Ayurveda and Hospital, SH 17
Anchepalya, Kumbalagodu post, Bangalore- 560074, Karnataka,
India
Bangalore
Bangalore
KARNATAKA |
09148774489
prashanthsuprashanthsu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dharmasthala Manjunatheswara Ayurveda and Hospital |
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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi kashaya, Reference: Haritha samhita kushta chikitsa 39/28-29adyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Chakradatta Kushta Chikitsa Adhyaya, Procedure details: Vidangadi lepa External application with Gomutra once a day after drying wash it off with warm water )
(1) Medicine Name: Vidangadi lepa, Reference: Chakradatta Kushta Chikitsa Adhyaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 30 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Patoladi kashaya, Reference: Sahasrayoga kashaya prakrana , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushna jala), Additional Information: - | | 4 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Chakradatta Kushta Chikitsa Adhyaya, Procedure details: Vidangadi lepa External application with Gomutra once a day after drying wash it off with warm water )
(1) Medicine Name: vidangadi lepa, Reference: Chakradatta Kushta Chikitsa Adhyaya, Route: Topical, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age of 20 and 60 years with irrespective of sex, religion and socioeconomic
status11.
2. Duration of disease less than 10 years
3. Patient diagnosed as vicharchika on basis of lakshanas like kandu, atiruja, daha, shyava,
rukshata.
4. Patients with the signs and symptoms of atopic dermatitis
5.Patients who are ready to give their consent. |
|
| ExclusionCriteria |
| Details |
1.Patient age below 20 and Above 60 years
2. Patient diagonsed with Uncontrolled diabetes mellitus, HBsAG positive, uncontrolled
hypertension.
3. Other dermatitis like wet eczema, contact dermatitis, dyshidrotic eczema, neurodermatitis,
nummular eczema, stasis dermatitis, seborrheic dermatitis
4.Alcohol and drug abuse
5.Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement noticed in signs and symptoms of Vicharchika through EASI SCALE (Eczema
area and severity index) |
0th day (Baseline), 15th day, 30th day and 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement noticed in
. Kandu (itching)
. Daha (burning sensation)
. Atiruja (severe pain)
. Rukshata (dryness)
. Shyava varna (discoluration) |
0th day (Baseline), 15th day, 30th day and 45th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A Controlled clinical study on the efficacy of Guducyadi kashaya in the management of Vicharchika (Atopic dermatitis) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Vicharchika (Atopic dermatitis) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group) 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Guducyadi kashaya internally in the dose of 50ml in the morning and Night 20mins before food followed by ushnajala pana along with Vidangadi lepa as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on Oth day(baseline), 15th day, 30th day and after trial on 45th day. Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Patoladi kashaya internally in the dose of 50ml in the morning and Night 20mins before food followed by ushnajala pana along with Vidangadi lepa as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on Oth day(baseline), 15th day, 30th day and after trial on 45th day. The primary outcome measure will be significant improvement noticed in signs and symptoms of Vicharchika through EASI SCALE (Eczema area and severity index) after 30 days. The secondary outcome measure will be improvement noticed in Kandu (itching) • Daha (burning sensation) • Atiruja (severe pain) • Rukshata (dryness) • Shyava varna (discoluration) after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment |