| CTRI Number |
CTRI/2025/12/098454 [Registered on: 04/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare how well different Sorozema treatments work and how safe they are in adults with a common scaly skin condition. |
|
Scientific Title of Study
|
A randomized, controlled, parallel-arm, open-label clinical study comparing
the efficacy and safety of sorozema oral-topical combination therapies in
adults with mild to moderate plaque psoriasis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/25-26/021 Version: 1.00 dated 12th November 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shraddha Patil |
| Designation |
Principal Investigator |
| Affiliation |
Ayushri Multispecialty Hospital |
| Address |
OPD no. 1 Ground floor, Ayushri Multispecialty Hospital Samadhan Chowk Pimprigaon pimpri
-
Pune
MAHARASHTRA
411017
India |
| Phone |
7709502751 |
| Fax |
- |
| Email |
drshraddhapatil27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Devendra Soman |
| Designation |
Technical officer |
| Affiliation |
Sonark Pharmaceuticals Pvt. Ltd |
| Address |
J-13/17 Additional MIDC Satara
-
Satara
MAHARASHTRA
415004
India |
| Phone |
02162240480 |
| Fax |
02162 240480 |
| Email |
aratiwagh007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arati Devendra Soman |
| Designation |
Technical officer |
| Affiliation |
Sonark Pharmaceuticals Pvt. Ltd |
| Address |
J-13/17 Additional MIDC Satara
-
Satara
MAHARASHTRA
415004
India |
| Phone |
02162240480 |
| Fax |
02162 240480 |
| Email |
aratiwagh007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nisarga Biotech Pvt. Ltd. J-2/1, Additional MIDC, Satara ,Maharashtra ,India,415001 |
|
|
Primary Sponsor
|
| Name |
Nisarga Biotech Pvt. Ltd. |
| Address |
J-2/1 Additional MIDC Satara |
| Type of Sponsor |
Other [ Private Company] |
|
|
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 Shraddha Patil |
Ayushri Multispecialty Hospital |
OPD no.1 Ground floor ,Samadhan Chowk,Pimprigaon, Pimpri
Pune
MAHARASHTRA |
7709502751
-
drshraddhapatil27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sangvi Multispecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A [Sorozema capsule (oral) + Sorozema oil (Topical)] |
One Sorozema capsule twice daily morning and evening after food for 120 days. Sorozema topical oil 2–5 mL or as required to completely cover all psoriatic lesions including newly appearing or recently cleared areas twice daily after cleaning the area properly once in the morning and once at night before bedtime approximately 10-12 hours apart Massage gently until absorbed. |
| Intervention |
Group B [Sorozema capsule (oral) + Sorozema cream (Topical)]: |
Participants will receive one Sorozema capsule twice daily morning and evening after food for 120 days.
Apply a thin, uniform layer of Sorozema topical cream to all psoriatic lesions, including newly appearing or recently cleared areas, twice daily after cleaning the area properly once in the morning and once at night before bedtime approximately 10-12 hours apart.Spread evenly until absorbed. |
| Comparator Agent |
NO |
NA |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Male or female participants aged 30 to 60 years inclusive.
2.A confirmed diagnosis of plaque psoriasis for at least 6 months involving the skin, scalp, or both, For group B the application of cream to scalp will not be recommended.
3.Participants diagnosed with plaque psoriasis with a PASI score must be between 3-20 both inclusive mild to moderate chronic plaque psoriasis. Participants who have previously received topical corticosteroids or other topical antipsoriatic agents, provided they have completed the required washout period prior to randomization 2 weeks for topical corticosteroids and vitamin D analogs.
4.Participants who have not received systemic antipsoriatic therapy example methotrexate, cyclosporine, systemic corticosteroids, apremilast, or biologics within the required washout period prior to randomization typically 4 weeks for systemic corticosteroids and conventional systemic therapies 8–16 weeks for biologics.
5.Women of childbearing potential and men must agree to use adequate contraception hormonal or barrier methods, or abstinence before entering the study, during participation, and for at least 4 weeks after study withdrawal.
6.Ability to understand and willingness to sign a written informed consent document at the screening visit before any study-specific procedures.
|
|
| ExclusionCriteria |
| Details |
1.Prior use of TNF-alpha inhibitor therapy at any time before screening.
2.Presence of spontaneously improving or rapidly worsening plaque psoriasis, or diagnosis of acute guttate, pustular, inverse, or erythrodermic psoriasis, or psoriatic arthritis.
3.History or presence of any malignancy, including skin.
4.Serious dermatological infection within the past 3 months that required systemic therapy.
5.Any condition deemed by the investigator to pose risk or be detrimental to participation including but not limited to uncontrolled hypertension or severe cardiovascular, pulmonary (especially chronic obstructive pulmonary disease requiring steroid therapy), cerebral, hematologic, gastrointestinal, neurological, or psychiatric disorders.
6.Current use of medications known to worsen psoriasis, including Lithium, beta-blockers, antimalarials, or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).
7.Continuous use of Ayurvedic, Homeopathic, or Herbal products for at least 1 month, within the 3 months prior to screening.
8.Pregnant or lactating women.
9.History of substance abuse or heavy use of alcohol, drugs, or tobacco;
10.Any other condition, at the discretion of the investigator, that may interfere with the study results or compromise participant safety.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 the efficacy of the investigational products in improving psoriasis severity, symptoms, and quality of life and visual improvement through images. |
1.From screening to day 120.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in sleep-by-sleep quality questionnaire.
2.Changes in TNF alpha levels.
3.Change in Perceived stress scale (PSS) questionnaire score.
4.Assessment of Overall Improvement by participant and investigator.
5.Adverse events profile
6.Compliance and tolerability of the investigational product |
1.At screening and day 120.
2.At screening and day 120.
3.At screening and day 120.
4.Day 120.
5.At baseline, day 30, day 60, day 90 and day 120.
6.At baseline,day 30, day 60, day 90 and day 120. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
15/12/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Plaque psoriasis is a chronic inflammatory skin disease with limited long-term relief from many existing treatments. Sorozema, an Ayurvedic multi-component formulation (capsule, oil, and cream), contains natural ingredients with anti-inflammatory, immunomodulatory, antioxidant, and skin-regulating properties. Early evidence suggests potential benefits in reducing psoriasis symptoms such as scaling, redness, and thickened skin. This clinical study aims to scientifically evaluate the safety, efficacy, and tolerability of Sorozema formulations in managing plaque psoriasis and determine whether combined oral and topical use offers improved therapeutic outcomes. |