| CTRI Number |
CTRI/2022/01/039662 [Registered on: 21/01/2022] Trial Registered Prospectively |
| Last Modified On: |
20/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of TILAKUSUMADILEPA in skin disease |
|
Scientific Title of Study
|
A Comparative Phase 2 Clinical Study To Evaluate Efficacy Of Tilakusumadilepa And Vipadikahar Lepa In The Management Of Vipadika With Special Rereference To Palmo-Plantar 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 Shamala Sammaiah Elkapelli |
| Designation |
PG SCHOLAR |
| Affiliation |
AYURVED SEVA SANGHA, AYURVED MAHAVIDYALAYA |
| Address |
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik.
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik.
Nashik
MAHARASHTRA
422003
India |
| Phone |
8999145793 |
| Fax |
|
| Email |
shamlaelkapelli926@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Ekanath G Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
AYURVED SEVA SANGHA, AYURVED MAHAVIDYALAYA |
| Address |
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik.
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik.
Nashik
MAHARASHTRA
422003
India |
| Phone |
9699085576 |
| Fax |
|
| Email |
ekulkarni6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Ekanath G Kulkarni |
| Designation |
Associate Professor |
| Affiliation |
AYURVED SEVA SANGHA, AYURVED MAHAVIDYALAYA |
| Address |
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik.
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik.
Nashik
MAHARASHTRA
422003
India |
| Phone |
9699085576 |
| Fax |
|
| Email |
ekulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik. |
|
|
Primary Sponsor
|
| Name |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
| Address |
Ganeshwadi Panchavati Nashik |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Shamala Sammaiah Elkapelli |
OPD no 13 kayachikitsa Ayurved Seva Sangha;s Ayurved Mahavidyalaya Panchwati Nashik. |
Ayurved Hospital , Panchwati Nashik
Nashik
MAHARASHTRA |
8999145793
shamlaelkapelli926@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE AYURVED SEVA SANGHA ,AYURVED MAHAVIDYALAYA ,NASHIK |
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: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tilakusumadilepa, Reference: Bhiashajya kalpana, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vipadikaharlepa, Reference: Sahastrayog, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical signs and symptoms of vipadika - panipadsphutan,
vedana
Kandu
Kharasparshata
Strava
Patients of Age group - 18 - 60 years of Age.
Patients willing to participate in the study , who give written consent |
|
| ExclusionCriteria |
| Details |
Patients below 18 & above 60 years of age.
Patients with other uncontrolled systemic disorders like DM/ HTN/Cardiac disorders/leprosy/Tuberculosis/Malignancy will be excluded.
Patients with other skin diseases Like Ringworm, scabies, Eczema etc. |
|
|
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 |
| REDUCTION IN SIGN AND SYMPTOMS OF VIPADIKA |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| COST EFFECTIVE TREATMENT |
30 DAYS |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
01/02/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The diagnosed patients of Vipadika will be treated for group A with Tilakusumadilepa mentioned in Bhaishajya Ratnawali 125 gms for 30 days used twice a day as topical application.The comparative drug for group B with Vipadikahar lepa mentioned in Sahastrayog will be given 125 gms for 30 days used twice a day as topical application.Assessement criteria will be those patients with classical signs and symptoms of vipadika -
panipadsphutan vedana, Kandu, Khara sparshata,strava.Patients with other skin diseases Like Ringworm, scabies,
Eczema etc will be excluded from study.The patients will be selected from kayachikitsa opd no 13.. |