| CTRI Number |
CTRI/2020/03/024089 [Registered on: 19/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| 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
|
Management of Psoriasis with Kushtanashana rasa and Kutaja suryapaki taila -A clinical study |
|
Scientific Title of Study
|
A Randomised controlled parallel group clinical study to evaluate Kushtanashana rasa and panchatiktha ghritha guggulu with Kutaja patra suryapaki taila external application in the management of Eka Kushta w.s.r to Psoriasis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Supreetha M |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no- 304, Department of Kayachikitsa
21st KM, Kanakapura Road, Udayapura PO
Bangalore
KARNATAKA
560082
India |
| Phone |
8660550443 |
| Fax |
|
| Email |
supree99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelakanta J Sajjanar |
| Designation |
Assosciate proffessor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no- 304, Department of Kayachikitsa
21st KM, Kanakapura Road, Udayapura PO
Bangalore
KARNATAKA
560082
India |
| Phone |
9844812331 |
| Fax |
|
| Email |
neelkant.ayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Supreetha M |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no- 304, Department of Kayachikitsa
21st KM, Kanakapura Road, Udayapura PO
Bangalore
KARNATAKA
560082
India |
| Phone |
8660550443 |
| Fax |
|
| Email |
supree99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no- 05, Department of Kayachikitsa
Sri Sri College of Ayurvedic Science and Rsearch Hospital
21st KM, Kanakapura Road, Udayapura PO |
|
|
Primary Sponsor
|
| Name |
Dr Supreetha M |
| Address |
PG Scholar
Department of Kayachikitsa
21st KM Kanakapura Main road,Udayapura Post,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 SupreethaM |
Sri Sri College of Ayurvedic Science and Research Hospital |
Room no- 05, Department of Kayachikitsa Sri Sri College of Ayurvedic Science and Rsearch Hospital 21st KM, Kanakapura Road, Udayapura PO
Bangalore
KARNATAKA |
8660550443
supree99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kushtanashana Rasa |
Kushtanashana Rasa is a formulation containing churnas of Shireesha,haritaki,vibhitaki,chirabilwa,Kakodumbara, shudha tankana in equal quantity mixed in quantity sufficient of Gomutra, followed by 12gms of draksha.
Dosage: 12gm of churna, orally once daily for 49 days |
| Comparator Agent |
Panchatiktha ghritha guggulu and Kutaja Suryapaki Taila |
1.Panchatiktha Ghritha Guggulu is a tablet having Main ingredients :Nimba , Kantakari, Patola ,Guduchi, Vasa ,Shuddha guggulu,other ingredients :Patha, vidanga, bhallataka, suradaru, gajopakulya, yavakshra, sarjakshara, nagara, mishreya , kushta, tejovati, maricha vatsaka, deepyaka, agni, rohini, vacha ,kanamoola, yuktha, manjishta, ativisha, vishani and Water for decoction along with Ghritha.
Dosage:4 tablets, orally twice daily, after food for 49 days.
2.Kutaja Suryapaki taila is a taila having ingredients Kutaja and tila taila.Applied externally on lesions twice daily.
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.With classical signs and symptoms of Eka Kushta.
2. Presenting with signs and symptoms of Psoriasis.
3. The Subjects willing to give informed consent for research.
|
|
| ExclusionCriteria |
| Details |
1.Subjects aged <21 years and > 60 years of age .
2.Subjects suffering from complications of Psoriasis like Psoriatic arthritis .
3.Subjects suffering from Non–psoriatic conditions of skin, IHD, Immune compromised patients and other uncontrolled systemic diseases.
4.Disease which interferes with the course of disease and treatment.
5.Pregnant and Lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in PASI Scale score |
16th day,32nd day,49th day and 65th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in DLQI scale score |
16th day,32nd day,49th day and 65th 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
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2020 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis is one of the most common skin disease which has no permanent cure available.The current treatment modalities available are palliative lotions,ointments and PUVA (Psoralin Ultra Violet A) and Biologic injections which are very expensive and is recommended for long period of time. Psoriasis is having high recurrance rate and often the patient with Psoriasis experience diminished quality of life. Hence there is a need to contribute with safe and effective remedy for its treatment. Hypothesis: Null Hypothesis-H0 :The efficacy of Kushtanashana Rasa in the mangement of Eka kushta w.s.r to Psoriasis is insignificant. Research Hypothesis- H1 :1. The efficacy of Kushtanashana Rasa in the management of Eka kushta w.s.r to Psoriasis is significant. 2. The efficacy of Kushtanashana Rasa in the management of Eka kushta w.s.r to Psoriasis is significant in comparison to control groups. |