| CTRI Number |
CTRI/2024/10/075574 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of kitibh kushtha with Rajrajeshwar ras orally and siddharthk Tailam topically |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Rajrajeshwar Ras orally and Siddharthak Tailam topically in the management of Kitibh Kushtha with special refrance to Psoriasis in age group from 18-70 years. |
| 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 Supriya Bhaskarrao Kadam |
| Designation |
PG scholar |
| Affiliation |
Dayabhai maoji majithiya Ayurved mahavidyalaya Yavatmal, Maharashtra |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated
with L.K ayurved rugnalaya yavatmal Department of kayachikista
Ground floor Opd no : 10
Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
431605
India |
| Phone |
8329174065 |
| Fax |
|
| Email |
supriyakadam2324@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Yogesh P. Duddalwar |
| Designation |
Associate professor |
| Affiliation |
Department of Kayachikitsa, DMM ayurved Mahavidyalaya Yavatmal |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated
with L.K ayurved rugnalaya yavatmal Department of kayachikista
Ground floor Opd no : 10
Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9423624476 |
| Fax |
|
| Email |
dr.yogesh.duddalwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya Bhaskarrao Kadam |
| Designation |
PG scholar |
| Affiliation |
Dayabhai maoji majithiya Ayurved mahavidyalaya Yavatmal, Maharashtra |
| Address |
Dayabhai mavaji majitiya ayurved Mahavidyalaya Yavatmal affiliated
with L.K ayurved rugnalaya yavatmal Department of kayachikista
Ground floor Opd no : 10
Yavatmal
MAHARASHTRA
445001
India
Yavatmal
MAHARASHTRA
431605
India |
| Phone |
8329174065 |
| Fax |
|
| Email |
supriyakadam2324@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMM ayurved Mahavidyalaya afiliated with L.K Ayurved rugnalaya Shivaji nagar Arni road
yavatmal, 445001 |
|
|
Primary Sponsor
|
| Name |
DMM ayurved Mahavidyalaya Yavatmal |
| Address |
Department of Kayachikitsa, DMM ayurved Mahavidyalaya,shivaji
nagar arni road Yavatmal |
| 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 Supriya Bhaskarrao Kadam |
DMM ayurved Mahavidyalaya, Yavatmal. |
Opd no 10,Department
of Kayachikista,DMM
Ayurved college
yavatmal,Shivaji nagar,
arni road, Yavatmal
Yavatmal
MAHARASHTRA
Yavatmal
MAHARASHTRA |
8329174065
supriyakadam2324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee DMM ayurved Mahavidyalaya Yavatmal |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Somraji tailam, Reference: Bhaishajya Ratnavali Chapter 54/ Shlok 312-314, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshanjala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rajrajeshwar Rasa, Reference: Bhaishajya Ratnavali Chapter 54/ Shlok 133-136, Route: Oral, Dosage Form: Rasayoga, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshanjala), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kushthakalanal Rasa, Reference: Bhaishajya Ratnavali 54/Shlok 152-153, Route: Oral, Dosage Form: Rasayoga, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshanjala), Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Siddharthak tailam, Reference: Gadnigrah Chapter 2/Shlok 532-535, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Koshanjala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group above 18 and below 70 years.
2) Patient having classical signs and symptoms of kitibh kushtha
Symptoms: -
A) Kinakhara sparsha (Scaling),
B) Ugrakandu (Severe pruritis)
C) Parusha (Dryness),
D) Srava (Dischange),
E) Vritta (Oval to round Lesions),
F) Ghana (Elevation),
G) Shyawan (Greyish Discolouration),
H) Snigdha Krushna (Erythematous Plaques)
3) Patient willing for clinical trial. Irrespective of gender, occupation, Religion, economical Barrier.
4) Patient who will fulfil criteria and take regular medicines with regular follow up.
|
|
| ExclusionCriteria |
| Details |
1) Age group below 18 years and above 70 years.
2) Pregnant and lactating mother.
3) Infective origins like
a) Koch ‘s disease
b) Hansen ‘s disease
c) Scabies
d) Eczema
e) Fungal infection /herpes zoster.
4) Immune compromised like HIV
5) Diabetic wound
6) Malignancies
7) Renal diseases like CKD
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
In present clinical trial, the patients was
diagnosed on the basis of signs and symptoms
describe in ayurvedic text i. e subjective criteria
A) Kinakhara sparsha (Scaling),
B) Ugrakandu (Severe pruritis)
C) Parusha (Dryness),
D) Srava (Dischange),
E) Vritta (Oval to round Lesions),
F) Ghana (Elevation),
G) Shyawan (Greyish Discolouration),
H) Snigdha Krushna (Erythematous Plaques)
|
Follow up on every 7th day in first 45 days (during treatment) and on every 15th day in Next 45 days (After treatment) up to the 3 months (90 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)PASI Scale (Psoriasis Area And Severity Index)
2)DLQI Scale (Dermatology Life Quality Index)
CBC
ESR
BSL
Above investigations & other required investigations will be carried out to rule out Serious illness if any & whenever they are necessary.
|
During treatment – 45 days (Follow up on 8th, 15th,22nd,29th,36th ,45th day)
After treatment – 45 days (Follow up on 60th, 75th, 90th day)
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/12/2024 |
| 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
|
Kitibha Kushtha is one of the Kshudra Kushtha. Here Tridosha, Rasa, Rakta, Mamsa, Ambu are affected. Rakta Dusti is the main cause of Twak Vikaras.kushtha is one among the Ashtamahagada. There is the involvement of Tridosha in all Kushtha but the predominance of Dosha makes the types & manifestations of Kushtha different.Among different types of Kushtha Kitibha Kushtha is described as one with symptoms like Kinakhara sparsha (Scaling), Ugrakandu (Severe pruritis), Parusha (Dryness), Srava (Dischange), Vritta (Oval to round Lesions), Ghana (Elevation), Shyawan (Greyish Discolouration), Snigdha Krushna (Erythematous Plaques). Kitibha Kushtha is predominantly caused by vitiated Kapha and Vata. |