| CTRI Number |
CTRI/2025/04/084005 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the combined effect of Neem and Goosberry powder internally and Cassia occidentalis root powder externally in Psoriasis |
|
Scientific Title of Study
|
An open label single arm clinical study to evaluate the combined effect of Arishta Amalaki choorna and Kasamada moola lepa in Kitibha [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 Anbumalar R |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital |
| Address |
Department of kayachikitsa
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital
BM road Thanniruhalla
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9361251383 |
| Fax |
|
| Email |
anburamsen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbumalar R |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital |
| Address |
Department of kayachikitsa
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital
BM road Thanniruhalla
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9361251383 |
| Fax |
|
| Email |
anburamsen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmiprasad L Jadhav |
| Designation |
Professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital |
| Address |
Department of kayachikitsa
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital
BM road Thanniruhalla
Hassan 573201
Hassan
KARNATAKA
573201
India |
| Phone |
9886614116 |
| Fax |
|
| Email |
drjadhav@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda andd Hospital
BM road Thanniruhalla,
hassan 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road Thanniruhalla,
hassan 573201 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SDM College of Ayurveda and Hospital BM road Thanniruhalla hassan |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM road Thanniruhalla,
hassan 573201 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anbumalar R |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Department of kayachikitsa
Shri Dharmasthala Manjunatheshwara college of Ayurveda and hospital
BM road Thanniruhalla
Hassan 573201
Hassan
KARNATAKA |
9361251383
anburamsen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASHTALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL , HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ARISHTA AMALAKI CHOORNA , Reference: Bhaishajya ratnavaali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information: -(2) Medicine Name: KASAMARDA MOOLA CHOORNA, Reference: Bhaishajya ratnavaali, Route: Topical, Dosage Form: Churna/ Powder, Dose: 1(NA), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: external application along with kanji. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Less than 1 year of chronicity
2.Subbjeccts willing to participate in study and ready to sign informed consent form |
|
| ExclusionCriteria |
| Details |
1.uncontrolled diabetes mellitus (HBA1C more than 8mg/dl)
2.pregnant and lactating women
3.subjects with impaired cardiac, renal and hepatic functions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be based on the presence of symptoms of kitibha, i.e.Syaava varna,
Kinaka sparsha parushata,
kandu,
rukshata,
|
0th day. 16th day and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psoriasis Area Severity Index Score |
0th day. 16th day and 31st day |
|
|
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 1 |
|
Date of First Enrollment (India)
|
20/04/2025 |
| 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
|
The study title is An Open Label Single Arm Clinical Study to Evaluate the Combined Effect of Arishta Amalaki choorna and Kasamarda moola lepa in Kitibha kushta (Psoriasis) which involves a total of 30 participants in the study, which includes age from 18 years to 60 years and less than 1 yea of chronicity and study exclude uncontrolled diabetic mellitus, pregnant and lactating women, Assessment will be done on 0th, 16th, 31st day after treatment and resulys of the following study will be analysed and calculated by using SPSS and other suitable statistical software. |