| CTRI Number |
CTRI/2025/03/082982 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Role of Panchakarma Procedures in the management of Psoriasis |
|
Scientific Title of Study
|
Effect of Vamana karma or Virechana karma followed by Saptasama Gutika and Saptasama Gutika alone on the Antioxidant w.s.r. to Superoxide Dismutase in the management of Ekakushtha (Psoriasis) - An Open Labelled Randomized Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sameer Khan |
| Designation |
MD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat |
| Address |
Department of Panchakarma, 4th floor, Institute of Teaching and
Research in Ayurveda,Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9920429433 |
| Fax |
|
| Email |
sameerkhan707.sk5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
HOD |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat |
| Address |
Department of Panchakarma, 4th floor, Institute of Teaching and
Research in Ayurveda,Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anup Thakar |
| Designation |
HOD |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat |
| Address |
Department of Panchakarma, 4th floor, Institute of Teaching and
Research in Ayurveda,Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9427776660 |
| Fax |
|
| Email |
anup_thakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institue of Teaching and Research in Ayurveda,Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda |
| Address |
Opp. B-Divison Police Station, Gurudwara Road,jamnagar,Gujarat
361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sameer Khan |
PG Hospital, Institute of Teaching and Research in Ayurveda |
OPD NO-12,PG Hospital,Institute of Teaching and Research in Ayurveda
Jamnagar
GUJARAT |
9920429433
sameerkhan707.sk5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, Institute of Teaching and Research in Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charaka chikitsa 7/43, Procedure details: Deepana pachana with trikatu churna 3g bd with lukewarm water for 3 to 7 days
Snehapana with goghrita for 3 to 7 days
Sarvanga abhyanga with sahchara taila f/b bashpa swedana on previous day and on the day of vamana Vamana karma with Kutaja, madanphala yashti churna with patola nimba hima for 1 day
Samsarjana krama depending on shuddhi
Shamana with Sapta sama gutika 500mg BD for 28 days)
(1) Medicine Name: Kutaja , Madanaphala, Yashti, Reference: Charaka chikitsa 7/43, Route: Oral, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Duration: 1 Days(2) Medicine Name: Neemba patola, Reference: Charaka chikitsa 7/43, Route: Oral, Dosage Form: Sheeta/Hima, Dose: 100(ml), Frequency: od, Duration: 1 Days(3) Medicine Name: Saptasama gutika, Reference: Ashtang hridaya chikitsa 19/43, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 28 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charaka chikitsa 7/44, Procedure details: Deepana pachana with trikatu churna 3g bd with lukewarm water for 3 to 7 days
Snehapana with goghrita for 3 to 7 days
Sarvanga abhyanga with sahchara taila f/b bashpa swedana for 3 days and on the day of virechana
Virechana karma with Triphala kwatha 80-100ml, Trirvutta churna 30-50gm, Danti 5-10 gm for 1 day
Samsarjana krama depending on shuddhi
Shamana with Sapta sama gutika 500mg BD for 28 days)
(1) Medicine Name: Trivrutta tripahala danti yoga, Reference: Charaka chikitsa 7/44, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 150(ml), Frequency: od, Duration: 1 Days | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Saptasama gutika, Reference: Ashtang hridaya chikitsa 19/43, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Willing and able to participate in the study
2)Patient having sign and symptoms of Ekakushtha (Psoriasis) which are mentioned in diagnostic criteria
3)Chronicity of disease less than 10 years
4)Patients Yogya for Vamana Karma and Virechana Karma as per Ayurvedic classics
|
|
| ExclusionCriteria |
| Details |
1)Age below 18 years and more than 60 years
2)Pregnant and lactating women
3)Chronicity of disease greater than 10 years
4)Uncontrolled D.M., HTN, Cancer, T.B., Heart disease
5)Patient Ayogya for Virechana Karma and Vamana Karma
6)Pustular type of psoriasis
7)Other concomitant skin disease occurring with Ekakushtha or allergic reaction of any other disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is expected that the trial may Increase the level of Superoxide Dismutase levels.
It may also provide relief in signs and symptoms of Ekakushtha (psoriasis).
|
Group-A 45-48 Days
Group-B 45-50 Days
Group-C 45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Psoriasis Area & Severity Index (PASI) score from baseline |
Group-A 45-48 Days
Group-B 45-50 Days
Group-C 45 Days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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
|
Introduction:Skin disorders are collectively referred to as "Kushtha" in Ayurveda which are further divided into two main categories: Maha Kushtha (severe skin conditions) and Kshudra Kushtha (milder skin conditions). Ekakushtha falls under the category of Kshudra Kushtha. Ayurvedic texts classify all forms of Kushtha as manifestations of "Tridosha," indicating that they involve an imbalance of the three doshas.Psoriasis is compared with Ekakushtha because it aligns more closely with psoriasis than other types of Kushtha. The dosha-dushya (body humor and tissue) imbalance in Ekakushtha is characterized by a predominance of Vata and Kapha doshas.Psoriasis is exacerbated by Oxidative Stress. Superoxide Dismuatase constitute an important antioxidant defence against oxidative stress in the body. Significance: Psoriasis is a challenging problem globally. Near about 125 million people worldwide, 2 to 3% of total population have psoriasis, according to the World Psoriasis Day consortium. With a prevalence of 0.44-2.8% in India, it commonly affects individuals in their third or fourth decade with males being affected two times more common than females. The primary treatment approach for Kustha involves frequent Sodhana procedures including Vamana and Virechana Procedures. Saptasama Gutika possesses Kusthaghna and Rasayana Properties. Till now no study has been reported on effect of Vamana Karma or Virechana Karma followed by Saptasama Gutika and Saptasama Gutika alone on the level of Superoxide dismutase in Ekakustha (Psoriasis). Aim & Objectives: To evaluate and compare the Vamana Karma or Virechana Karma followed by Saptasama Gutika and Saptasama Gutika alone increase the level of Superoxide Dismutase in Ekakushtha (Psoriasis). Materials and Methods: 30 Diagnosed and newly diagnosed Patients of Psoriasis will be enrolled in three groups. Group A patients will receive intervention with Vamana karma Followed by Saptasama Gutika. Group B patients will receive Virechana karma Followed by Saptasama Gutika. Group C patients will recive saptasama Gutika alone.
|