| CTRI Number |
CTRI/2023/06/053671 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trail to evaluate the effect of Ayurvedic medicines (Mahamanjishthadi kwath, Kaishora guggulu, Panchatikta ghrita, Eranda taila) in the management of ekakushtha W.S.R. to psoriasis. |
|
Scientific Title of Study
|
Clinical evalution of Ayurvedic intervention (Mahamanjishthadi kwath, Kaishora guggulu, Panchatikta ghrita, Eranda taila) in the management of ekakushtha 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 |
Alpesh Munjani |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurveda College |
| Address |
Department of Kayachikitsa, OPD 4, Government Akhandanand Ayurveda College and Hospital, Bhadra
Ahmadabad
GUJARAT
380001
India |
| Phone |
8238223403 |
| Fax |
|
| Email |
alpeshmunjani2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anamika Soni |
| Designation |
Associated Professor |
| Affiliation |
Government Akhandanand Ayurveda College |
| Address |
Department of Kayachikitsa, OPD 4, Government Akhandanand Ayurveda College and Hospital, Bhadra
Ahmadabad
GUJARAT
380001
India |
| Phone |
9269533108 |
| Fax |
|
| Email |
ayursoni@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anamika Soni |
| Designation |
Associated Professor |
| Affiliation |
Government Akhandanand Ayurveda College |
| Address |
Department of Kayachikitsa, OPD 4, Government Akhandanand Ayurveda College and Hospital, Bhadra
Ahmadabad
GUJARAT
380001
India |
| Phone |
9269533108 |
| Fax |
|
| Email |
ayursoni@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurveda College, Bhadra, Ahmedabad 380001 |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurveda College |
| Address |
Department of Kayachikitsa, OPD 4, Government Akhandanand Ayurveda College and Hospital, Bhadra |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Alpesh Munjani |
Government Akhandanand Ayurveda College |
Department of Kayachikitsa, OPD 4, Government Akhandanand Ayurveda College and Hospital, Bhadra
Ahmadabad
GUJARAT |
8238223403
alpeshmunjani2012@gmail.com |
|
|
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:L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchatikta ghrita , Reference: Sharangdhar samhita, Madhyam khanda, 9/85-86, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Ushnodak ), Additional Information: Panchatikta ghrita will be given for local application too. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kaishora guggulu, Reference: Sharangdhara Samhita, Madhyam khanda, Adhyay -2 Sloka-71 to 82, Route: Oral, Dosage Form: Guggulu , Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: Ushnodak), Additional Information: | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahamanjishthadi kwath, Reference: sharangdhara samhita, Madhyam khanda, Adhyaya - 2 Sloka - 139 to 144, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eranda taila, Reference: Charak Samhita Sutra sthan adyay 27 Slok 289, Route: Oral, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: Ushnodak), Additional Information: Initially it will be given for 3days, then it will be given for once a week for koshtha suddhi. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical signs & symptoms of Ekakushtha.
Patients having chronicity less than ten years duration. |
|
| ExclusionCriteria |
| Details |
Chronicity more than ten years.
Pregnant and Lactating women.
Patients with psoriatic arthropathy.
Patients with uncontrolled DM and HTN.
K/C/O severe heart diseases, kidney diseases, stroke, liver diseases
K/C/O severe systemic illness like R.A., Gout, S.L.E. etc.
K/C/O pulmonary dysfunction or COPD
Patients with history of any acute or chronic infectious diseases like TB, AIDS, Other STDs.
Patients taking medications like corticosteroids, hormonal therapy, anti-depressants or any other drugs which may affect outcome of the study.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Results will be assessed on the basis of sign & symptoms of Ekakushtha.
Aswedanam (Anhydrosis)
Mahavastu (Extensive lesion)
Matsyashakalopamam (Scalig)
Kandu (Itching)
Rukshata (Dryness) |
Weekly assessment will be done for 6 weeks during trail & for 2 weeks after drug trail. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Results will be assessed on the basis of PASI score, DLQI, Candle grease sign, Auspitz sign, Kobners phenomena |
Weekly assessment will be done for 6 weeks during trail & for 2 weeks after drug trail |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/06/2023 |
| Date of Study Completion (India) |
30/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
CLINICAL EVALUTION OF AYURVEDIC INTERVENTION (MAHAMANJISHTHADI KWATHA, KAISHORA GUGGULU, PANCHATIKTA GHRITA, ERANDA TAILA) IN THE MANAGEMENT OF EKAKUSHTHA W.S.R. TO PSORIASIS.
Patients will be diagnosed on the basis of classical signs and symptoms of Ekakushtha described in Ayurvedic classics and clinical tests like - PASI score, Auspitz sign, Kobner’s phenomena, Candle grease sign. Total 30 patients will be included in trail based on inclusion, exclusion criteria. Initially Koshtha suddhi will be done by erandataila for 3days then trail drugs - Mahamanjishthadi kwath, Kaishora guggulu, Panchatikta ghrita will be given for 6 weeks and weekly koshtha suddhi will be done by eranda taila. Patient assessement will be done based on subjective and objective criteria. |