| CTRI Number |
CTRI/2023/06/053429 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
23/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of topical application of rice starch mixed with Yashtimadhu choorna and rice strach mixed with turmeric powder on patients with Kitibha kushta or Psoriasis |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of topical application of rice starch fortified with Yashtimadhu choorna in the management of Kitibha kushta with special reference to Psoriasis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Buvana V Mundargi |
| Designation |
PG scholar |
| Affiliation |
Sri Sri college of Ayurvedic science and research, |
| Address |
Sri Sri college of Ayurvedic science and research,
Survey #269/270, B.M. Kaval, Udayapura P.O., 21km, Kanakpura road, Bangalore- 82
Bangalore
KARNATAKA
560082
India |
| Phone |
8861605679 |
| Fax |
|
| Email |
buvanavm2109@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sajitha K |
| Designation |
Head Of Department, Professor |
| Affiliation |
Sri Sri college of Ayurvedic Science and Research |
| Address |
Sri Sri college of Ayurvedic science and research, 21st km, Kanakapura road, Udayapura, Bangalore- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9448415810 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sajitha K |
| Designation |
Head Of Department, Professor |
| Affiliation |
Sri Sri college of Ayurvedic science and research |
| Address |
Sri Sri college of Ayurvedic science and research, 21st km, Kanakapura road, Udayapura, Bangalore- 560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9448415810 |
| Fax |
|
| Email |
sajithak96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri college of Ayurvedic science and research, 21st km, Kanakapura road, Udayapura, Bangalore - 82 |
|
|
Primary Sponsor
|
| Name |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH |
| Address |
21st KM, Kanakpura Road, Udayapura, Bangalore - 560082 |
| 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 Buvana V Mundargi |
Sri Sri Ayurveda hospital |
Room no. - 07. Department of Swasthavritta. 21st km, Kanakpura road, Udayapura, Bangalore - 560082
Bangalore
KARNATAKA |
8861605679
buvanavm2109@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL COMMITTEE, Bengaluru |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Topical Application | Rice starch fortified with Turmeric powder should be applied all over the psoriatic lesions and allowed to dry in the sunlight for about 25-30mins once a day for 14days. | | 2 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Textbook of Naturopathy, Procedure details: Rice starch fortified with Yashtimadhu choorna should be applied all over the psoriatic lesions and allowed to dry in the sunlight for about 25-30mins once a day for 14days.)
(1) Medicine Name: Yashtimadhu choorna, Reference: Textbook of Naturopathy, Route: Topical, Dosage Form: Lepa Churna, Dose: 100(g), Frequency: od, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with PASI score < 10.
Subject of the age group between 20 to 60 years irrespective of their gender,
Subjects who are willing to participate in the study by giving a written consent. |
|
| ExclusionCriteria |
| Details |
Subjects suffering from any other systemic disorders.
Subjects suffering from complications of Psoriasis like Psoriatic Arthritis.
Subjects under long term medications like NSAIDS, Anti-histamines etc.
Subjects who are pregnant and lactating.
Subjects who are not willing to participate in the study. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the psoriatic lesions on 14th day of the study |
0th day, 14th day, 21st day and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptom of itching of the psoriatic lesions on the 14th day of the study |
0th day, 14th day, 21st day 28th 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 3 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Study type - Randomized Active Controlled Clinical Study, pre and post test study; Timing - Prospective; Masking - Open label; Grouping - Double arm; Randomization - Lottery method; Group intervention method - parallel.| Features | Trail group - A | Control group - B | | Sample size | 15 | 15 | | Intervention | Rice starch fortified with Yashtimadhu choorna | Rice starch fortified with Turmeric powder | | Route | topical | topical | | Time | OD (before 10am) | OD (before 10am) | | Duration | 25-30mins | 25-30mins | | Trail period | 14 days | 14 days | | Study duration | 28 days | 28 days | | Assessment | 0th and 14th day | 0th and 14th day | | Follow up | 21st and 28th day | 21st and 28th day |
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