| CTRI Number |
CTRI/2025/02/080163 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| 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 SEE DIFFERENCE BETWEEN EFFECT OF KAISORA GUGGULU WITH MANJISTHADI KWATH AND EKAVINASATIKO GUGGULU WITH NISHADI KWATH IN THE MANAGEMENT OF PSORIASIS |
|
Scientific Title of Study
|
A CLINICO-COMPARATIVE STUDY OF KAISORA GUGGULU WITH MANJISTHADI KVATHA AND EKAVINSATIKO GUGGULU WITH NISADI KVATHA IN THE MANAGEMENT OF PSORIASIS |
| 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 Manali Chauhan |
| Designation |
2nd Year PG Scholar |
| Affiliation |
J.S Ayurveda |
| Address |
Post Graduate Department of kaya chikitsa, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT
387001
India |
| Phone |
9512773334 |
| Fax |
|
| Email |
chauhanmanali1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Manish Patel |
| Designation |
Professor and HOD |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital Nadiad |
| Address |
Post Graduate Department of kaya chikitsa, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Manish Patel |
| Designation |
Professor and HOD |
| Affiliation |
J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital Nadiad |
| Address |
Post Graduate Department of kaya chikitsa, J.S. Ayurveda Mahavidyalaya, College Road, Nadiad, Kheda, Gujrat
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
|
| Email |
manishayu97@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda pharmacy, J S Ayurveda Mahavidyalaya and P D Patel Ayurvedic Hospital,Collage road Nadiad, kheda,Gujrat 387001 |
|
|
Primary Sponsor
|
| Name |
J S Ayurveda Mahavidyalaya |
| Address |
J S Ayurveda Mahavidyalaya,Collage road,Nadiad 387001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| J S Ayurveda Mahavidyalaya |
J S Ayurveda Mahavidyalaya,Collage road,Nadiad 387001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manali |
P D Patel Ayurveda Hospital |
Post Graduate Department of Kayachikitsa, J.S. Ayurveda Mahavidyalaya and P D Patel Ayurvedic hospital, College Road, Nadiad, Kheda, Gujrat
Kheda
GUJARAT |
9512773334
chauhanmanali1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Manjisthadi kwath, Reference: Sharangadhara samhita by Dr. rahmanand Tripathi, Sharangadhara. Varanasi: Chaukhambha Surbharati Prakashana; 2017.Sharangadhara Samhita Madhyam Khanda, Kvathadi Kalpana 2/136-142, p. 102, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaisora Guggulu, Reference: Shrangadhara samhita by Dr. rahmanand Tripathi, Sharangadhara. Varanasi: Chaukhambha Surbharati Prakashana; 2017.Sharangadhara Samhita Madhyam Khanda, Vataka Kalpana; 7/70- 81, p. 136 , Route: Oral, Dosage Form: Guggulu , Dose: 900(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: jala), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ekavinsatiko guggulu, Reference: Yogaratnakara “vidhyotini tika” by Vaidhya Shreelaxmipatishashtri, Chow khamba Sanskrit series office, varanasi, India; kushtha Adhyay/1-5, p. 222, Route: Oral, Dosage Form: Guggulu , Dose: 900(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: jala), Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nishadi kwath , Reference: Ashtag Hridayam by Dr. ramhanand Tripathi, Chow khamba Sanskrit series office, varanasi, India , kushtha chikitsa 19/38 , p. 788, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Who fulfilled the diagnostic criteria mentioned as sign and symptom
Any three of these symptoms
1.Scaling
2.Itching (Kandu)
3.Erythema
4.Loss of perspiration
5.Dryness
Any one of these signs
1.Auspitz sign
2.Candle grease sign
3.Koebners phenomenon
Patients of age between 18 to 60 years and of both genders. |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating females.
1.Known cases of diseases like AIDS, STD, TB, heart diseases and other disorders that lead to fetal conditions for the patients.
2.Patients having diabetes mellitus.
3.Other concomitant skin diseases occurring with the allergic reaction of any other disease. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe and find out changes in signs and symptoms of psoriasis after the oral administration of above mentioned medicinnes |
A patient will be treated at O.P.D. level for 8 weeks of treatment. They will be instructed to visit the hospital every 2 weeks at intervals. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the changes in the PASI index in the patients of psoriasis.
2.To find out the improvement in quality of life through changes in DLQI in the patients of psoriasis. |
A patient will be treated at O.P.D. level for 8 weeks of treatment. They will be instructed to visit the hospital every 2 weeks at intervals. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2025 |
| 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 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
|
Psoriasis is a complex, chronic, multifactorial, inflammatory disease that involves hyper proliferation of keratinocytes in the epidermis, with an increase in the epidermal cell turnover rate. 20 patient of psoriasis who fulfill the inclusion criteria will be selected from opd and give them oral administration of khadirastak kwatha 40 ml twice a day and manjisthadi taila for local application twice a day. Patient will be treated for 8 weeks. Patients will be assessed before and after the treatment. |