| CTRI Number |
CTRI/2017/08/009533 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
23/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Yastimadhu bhavitha Kutala gulika in Eka Kushta |
|
Scientific Title of Study
|
Clinical study to assess the efficacy of Vamana with Yastimadhu bhavitha Kutaja gulika in Eka kushta(psoriasis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satish S Vasan |
| Designation |
Second year PG scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital |
| Address |
Department of panchakrama
OPD number 14
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital
Thanniruhalla
B.M. road
Hassan
Hassan
KARNATAKA
592312
India |
| Phone |
8105619850 |
| Fax |
08172256461 |
| Email |
drsatish.vasan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital |
| Address |
Department of panchakrama
OPD number 14
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital
Thanniruhalla
B.M. road
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9448705660 |
| Fax |
08172256461 |
| Email |
ashvinipanchakarma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashvini Kumar M |
| Designation |
Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital |
| Address |
Department of panchakrama
OPD number 14
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital
Thanniruhalla
B.M. road
Hassan
Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital
Thanniruhalla
B.M. road
Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9448705660 |
| Fax |
08172256461 |
| Email |
ashvinipanchakarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of panchakrama
OPD number 14
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
Thanniruhalla
B.M. road
Hassan District-573202 |
| Type of Sponsor |
Other [Ayurvedic Medical college 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 Satish S Vasan |
Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital Thanniruhalla B.M. Road Hassan |
Panchakarma OPD no.14
Hassan
KARNATAKA |
8105619850
08172256461
drsatish.vasan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjuntheshwara College of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Yastimadhu Bhavitha Kutaja gulika |
Yastimadhu Bhavitha Kutaja gulika
Dose 12 gms
Frequency once
Oral route of administration
Duration of therapy one day
given for Vamana karma |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Between the age of 18 to 70 years
Patient who are fit for vamana
Patients who are willing to give consent |
|
| ExclusionCriteria |
| Details |
Patients with cardiac diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Yastimadhu bhavitha Kutaja Gulika for vamana in Eka kushta(Psoriasis)
To evaluate the efficacy of Yastimadhu bhavitha Kutaja Gulika as vamaka yoga
Route of administration oral
frequency 1 time during vamana karma
duration of the study 14days
Out come will be accessed on 8th day after vamana karma |
To evaluate the efficacy of Yastimadhu bhavitha Kutaja Gulika for vamana in Eka kushta
(Psoriasis)
To evaluate the efficacy of Yastimadhu bhavitha Kutaja Gulika as vamaka yoga |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improve in the overall health of the patient
Reduced complaints of psoriasis |
7 days |
|
|
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)
|
01/03/2017 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Ayurvedic management of Pakshagataha (Right middle cerebral artery hemorrhagic infract): A case report
Published in IJRAP ON 2/8/2016 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It will be a single Armed open clinical study which includes pre-test and post test design wherein 30 patients suffering from ekakustha will be selected irrespective of their gender, caste or creed .30 patients suffering from ekakustha satisfying the inclusion exclusion and diagnostic criteria will be selected from IPD of SDM college of Ayurveda & Hospital, Hassan and in a single group. All subjects will be administer vamana in the following schedule: Deepana, Pachana (carminative and digestives) -Panchakolachurna 5g thrice daily 30 minutes before food with luke warm water till Niramavastha ( compleat digested stage, feeling of lightness) is obtained. Snehapana- ArohanaKrama Shodhananga Snehapana will be administered with Moorchita Ghrita till the Samyak Snigdha Lakshana or 7 days whichever is earlier. Vishramakala- One day Sarvanga abhyanga with Moorchita tila taila and Ushnajala snana will be done. In Vishrama Kala Kapha Utkleshakar diet- Morning- Idly,Vada, Lunch- Curd Rice, curd vada ,Dinner- milk and rice . Masha- Payasa, TilaLaddu(100gms) & Milk sweets(250gms) will also be advised to be taken within the whole day. PurvaKarma- On Vamana day the patient will be prepared with Sarvanga Abhyanga with Moorchitataila and Ushnajala Snana. Pradhana Karma –250 gm of snigdhayavagu ,Akanthapana of milk will be given prior to administration of VamanaYoga. Vamana Yoga –Yastimadhu bhavitha kutaja gulika : Each gulika measures about 500mg will administered according to patients and disease strength. finally the patient is evaluated for the relief in the psoriasis complaints. |