| CTRI Number |
CTRI/2025/04/083867 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
01/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study the effect of Panchatikta Ghruta internally in Psoriasis |
|
Scientific Title of Study
|
A Single arm clinical study to evaluate the efficacy of Shamana Snehapana with Panchatikta Ghruta in Vattotar Kushtha with special reference to 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 Neharika Rana |
| Designation |
MD Scholar Panchakarma |
| Affiliation |
Sumatibhai Shah ayurved mahavidyalaya, Hadapsar, Pune |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya OPD no 6, Department of Panchakarma, sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9607204350 |
| Fax |
|
| Email |
rana.neharika1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Gokhale |
| Designation |
Head of Department of Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, Pune |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya OPD no 6, Department of Panchakarma, sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neharika Rana |
| Designation |
MD Scholar Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya, Hadapsar, Pune |
| Address |
Sumatibhai Shah Ayurved Mahavidyalaya OPD no 6, Department of Panchakarma, sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9607204350 |
| Fax |
|
| Email |
rana.neharika1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune 4110128 |
| 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 |
| Dr Neharika Rana |
Sane Guruji Arogya Kendra |
OPD No 6, Department of Panchakarma, Malwadi,Hadapsar
Pune
MAHARASHTRA |
9607204350
rana.neharika1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAMs Sumatibhai Shah Ayurveda Mahavidyalaya and Sane Guruji Arogya Kendra |
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: KUSHTHAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | snehapAna-karma, स्नेहपान-कर्म | (Procedure Reference: Charak samhita, Procedure details: intake of 30ml panchatikta ghruta early in the morning when the patient feels hungry for 15 days.)
(1) Medicine Name: panchatikta ghruta, Reference: sharangdhar samhita, Route: Oral, Dosage Form: Ghrita, Dose: 30(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed according to the classical features of Psoriasis.
Pre diagnosed patient of Psoriasis.
Patient between age group 20-50 years will be selected.
Patient having cardinal symptoms of Vatottar Kushtha like Ruksha, Shoola, Sankoch, Parushya, Asweda, Shyava/ Aruna Varna will be selected for study |
|
| ExclusionCriteria |
| Details |
Patients having symptoms of Kushtha suffering from other systemic disorder which interfere with interventions.
Pregnant women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Shamana Snehapana with Panchatikta Ghruta in Vattotar Kushtha in 15 days.
|
Treatment will be given for for 15 day. Assessment will be done on 0th, 7th and 15th day,
follow up after 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study the effect of Panchatikta Ghruta on lipid profile in 15 days.
2) To study the effect of Panchatikta Ghruta on PASI Score in 15 days. |
Treatment will be given for 15 days. Assessment of Lipid Profile and PASI score will be done on 0th and 15th day.
Follow up after 15 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
|
N/A |
|
Date of First Enrollment (India)
|
12/04/2025 |
| 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
|
This is a single arm clinical study to evaluate the efficacy of Shamana Snehapana with panchatikta ghruta in the management of Vattotar Kushtha (Psoriasis). In this study the patient will be given 30 ml panchatikta ghruta early in the morning, after defecation and when the patient feels hungry for 15 days. Assessment of Shamana Snehapana will be done on 0th, 7th and 15th day. Assessment of subjective criteria will be done on 0th, 7th, 15th and 30th day. Assessment of lipid profile and PASI score will be done on 0th and 15th day. Post assessment, follow up after 15 days. Observations will be drawn from the outcome of the interest. |