| CTRI Number |
CTRI/2020/11/029372 [Registered on: 25/11/2020] Trial Registered Prospectively |
| Last Modified On: |
24/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the add on effectiveness of khadira yavagu as food in the management of dadru kushta(tinea) |
|
Scientific Title of Study
|
A clinical study to evaluate the add on effectiveness of khadira as pathya in dadru kushta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Arsha K S |
| Designation |
Post Graduate Scholar, Department of Swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7034462952 |
| Fax |
|
| Email |
arshaks.91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapas Brata Tripathy |
| Designation |
Professor and HOD, Department of Swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7034462952 |
| Fax |
|
| Email |
drtbtripaty@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arsha K S |
| Designation |
Post Graduate Scholar, Department of Swasthavritta |
| Affiliation |
Sri Dharmasthala Manjunatheswara College of Ayurveda and hospital |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7034462952 |
| Fax |
|
| Email |
arshaks.91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Arsha K S,
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan 573201, Karnataka, India
|
|
|
Primary Sponsor
|
| Name |
Dr Arsha K S |
| Address |
Sri Dharmasthala Manjunatheswara College of Ayurveda and Hospital
BM Road Thanniruhalla
Hassan |
| 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 Tapas Brata Tripathy |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
B M Road, Thanniruhalla, hassan
Hassan
KARNATAKA |
9448705599
drtbtripaty@sdmcahhassan.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: DADRU-KUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A clinical study to evaluate the add on effectiveness of khadira as pathya in dadru kushta |
Shamana chikitsa with nimbadi kashaya 30ml BD, Gandhaka rasayana 2 BD, Sidharthaka snana churna E/A. |
| Intervention |
A Clinical study to evaluate the add on effectiveness of khadira as pathya in dadru kushta |
Shamana chikitsa with nimbadi kashaya 30ml BD, Gandhaka rasayana 2 BD, Sidharthaka snana churna E/A. Khadira in the form of yavagu 200ml BD and for pana (used instead of drinking water) for 1 month to study group while contol group is on shamana chikitsa only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients fulfilling the diagnostic criteria(itching, erythema, papules, raised lesions)
Subjects ready to sign the consent form |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating women
History of mental disorders
Patients under long-standing medications
Chronicity for more than 1 year
History with any infectious diseases like HIV, HbsAg |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A Clinical study to evaluate the add on effectiveness of khadira as pathya in dadru kushta |
A Clinical study to evaluate the add on effectiveness of khadira as pathya in dadru kushta in 0ne month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To reduce itching, erythema, papules and raised lesions |
15th day and after completion of study |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
30/11/2020 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SUMMARY OF STUDY : Diet plays an important role in skin diseases.Ayurveda prescribes specific diet patterns in diseased and healthy individual which are known as pathya. Kushta is considered as one of the Ashtamahagatas. Ayurveda mentions Khadira as agrya aushadha for kushta. It is mentioned that khadira can be used as ahara in the form of yavagu and for pana after shodhana in all types of kushta. Khadira possess kaphapitta hara property. Dadru kushta is kaphapitta predominant with classical lakshanas like kandu, raga, pidaka, utsannamandala. So an effort is made to evaluate the effectiveness of khadira as pathya in dadru kushta. OBJECTIVE OF STUDY : To evaluate the add on effectiveness of khadira as pathya in the form of khadira sidha yavagu and khadira sidha jala for pana in dadru kushta.. Total Sample Size – 30 Control group- Patients under medication for dadru. Trial group- Patients under medication for dadru along with khadira as pathya. Duration of the study- 30 days. Follow up: Subjects will be reviewed once in 15 days during study period and follow up will be done after 15 days of completion of study DOSAGE : Khadira Sidha Yavagu- Dosage – 200 ml Twice daily ( before food) Khadira Sidha Jala - Dosage – Used instead of water |