| CTRI Number |
CTRI/2026/01/101059 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Guggulu Marichadi taila (Topical) along with Rasamanikya (Oral) versus Rasamanikya (Oral) alone in the management of Psoriasis w.s.r. to Eka Kushta |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Guggulu Marichadi taila (Topical) along with Rasamanikya (Oral) versus Rasamanikya (Oral) alone in the management of Psoriasis w.s.r. to Eka Kushta |
| 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 Ashish Jamuna Parsad Dubey |
| Designation |
PG Scholar |
| Affiliation |
Padmashree Dr DY Patil Deemed to be University , School of Ayurveda. |
| Address |
DY Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, sector 7, Nerul east , Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
8692947685 |
| Fax |
|
| Email |
ash.dub.bams24@dypatil.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish H Mhatre |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr DY Patil Deemed to be University , School of Ayurveda. |
| Address |
DY Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, sector 7, Nerul east , Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9819639895 |
| Fax |
|
| Email |
ashish.mhatre@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish H Mhatre |
| Designation |
Associate Professor |
| Affiliation |
Padmashree Dr DY Patil Deemed to be University , School of Ayurveda. |
| Address |
DY Patil Ayurvedic Hospital, 1st floor, Kayachikitsa Department OPD No.1, sector 7, Nerul east , Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9819639895 |
| Fax |
|
| Email |
ashish.mhatre@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| Padmashree Dr DY Patil Deemed to be University , School of Ayurveda, sector 7 , Nerul east , Navi Mumbai ,400706 |
|
|
Primary Sponsor
|
| Name |
Dr. Ashish Dubey |
| Address |
Padmashree Dr DY Patil Deemed to be University , School of Ayurveda, sector 7 , Nerul east , Navi Mumbai ,400706 |
| 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 Ashish Dubey |
DY Patil Ayurvedic Hospital |
Padmashree Dr DY Patil Deemed to be University , School of Ayurveda ,1st floor , Kayachikitsa Department OPD No. 1, Nerul east , Navi Mumbai
Thane
MAHARASHTRA |
8692947685
ash.dub.bams24@dypatil.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Padmashree Dr DY Patil Deemed to be University , School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guggulu Marichadi Taila, Reference: Ashtanga Hridayam chikitsa sthan, Route: Topical, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Rasamanikya, Reference: Sidhabhaishajya manimala, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 60(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: ghee/honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasamanikya, Reference: Sidhabhaishajya manimala, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 60(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -ghee/honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with classical lakshana of eka
kushta(Psoriasis) and clinical features of
Psoriasis such as absence of sweating, extensive
localization, resembling the scales of fish.
2. Subjects of either sex between the age group of
18 and 60 years.
3. Subjects with duration of upto 5 years will be
selected.
4. Subjects with positive Auspitz sign. |
|
| ExclusionCriteria |
| Details |
1. Subjects with uncontrolled metabolic disorders
like hypothyroidism, hyperthyroidism , DM .
2. Subjects with other systemic disorders like
Epilepsy , Kochs , HIV , etc.
3. Eka kushta ( Psoriasis ) with extracutaneous
manifestations. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Guggulu Marichadi Taila along with Rasamanikya in the management of Psoriasis w.s.r. to Eka Kushta |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the the efficacy of Guggulu Marichadi Taila along with Rasamanikya and Rasamanikya alone in the management of Psoriasis w.s.r. to Eka Kushta |
2 months |
| To determine the combined efficacy of Rasamanikya and Guggulu Marichadi Taila in comparison to control. |
2 months |
| To observe and document any adverse effect or complications arising from the intervention during the study period. |
2 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
30/01/2026 |
| 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
|
A Randomized Controlled Clinical Study to evaluate the efficacy of Guggulu Marichadi taila (Topical) along with Rasamanikya (Oral) versus Rasamanikya (Oral) alone in the management of Psoriasis w.s.r. to Eka Kushta The study aims to evaluate the efficacy of Guggulu Marichadi Taila in the management of Eka kushth A total of 120 patients will be randomly assigned into two groups , the patients will be selected based on the subjective ( rukshata , size of psoriatic patch , arunatva, kandu) and objective criteria (Auspitz sign , Candle grease sign ) seen in Psoriasis . The medicine will be given for a total of 60 days and assessment will be done on the 0, 15th, 30 th and 60 the day . |