| CTRI Number |
CTRI/2023/05/052405 [Registered on: 09/05/2023] Trial Registered Prospectively |
| Last Modified On: |
01/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of gandhakadhya malahara in patients with palmo plantar psoriasis. |
|
Scientific Title of Study
|
A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Gandhakadhya Malahara Over Sarjarasadi Lepa Along With Arogyavardhini Vati In The Management Of Vipadika With Special Reference 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 Sunita |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Dr Sunita PG Scholar,Department of Kayachkitsa,BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur-586109
Bijapur
KARNATAKA
586109
India |
| Phone |
9465526481 |
| Fax |
|
| Email |
sunitabishnoi9898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
Principal and Professor,Department of Kayachikitsa ,BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur 586109
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
drsanjay_charaka@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita |
| Designation |
BAMS PG Scholar |
| Affiliation |
BLDEAs AVS AYURVEDA MAHAVIDYALAYA VIJAYAPURA |
| Address |
PG Scholar Department of Kayachiktsa,BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre Vijayapur-586109
Bijapur
KARNATAKA
586109
India |
| Phone |
9465526481 |
| Fax |
|
| Email |
sunitabishnoi9898@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEAS AVS AYURVEDA MAHAVIDYALAYA Hospital and Research centre, Bagalkot road,VIJAYAPUR-586109. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [Nil] |
|
|
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 Sanjay kadlimatti |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR |
Kayachikitsa 10 OPD BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR
Bijapur
KARNATAKA |
8970744656
drsanjay_charaka@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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:L089||Local infection of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VIPADIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Rasa tarangini, Procedure details: External application of Gandhakadya Malahar twice a day for 6 weeks)
(1) Medicine Name: Arogyavardhini Vati , Reference: Rasaratna samuchhaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 6 Weeks | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Rasa tarangini , Procedure details: External application of Gandhakadya Malahar twice a day for 6 weeks )
(1) Medicine Name: Arogyavardhini Vati , Reference: Rasaratna samuchhaya , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 6 Weeks |
|
|
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Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients having panipada sphutanam(cracks of hands and feet),tivra vedana(severe pain),kandu(itching),saraaga(reddish discolouration),pitika(papule)
|
|
| ExclusionCriteria |
| Details |
Patients suffering from haemolytic disorders,bleeding disorders,hereditary problems.
Patients suffering from any other major systemic disorders like diabetes mellitus,HIV etc.
Associated with other forms of skin diseases.
Pregnant women and lactating mothers. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduction in number of cracks in patients with vipadika |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in size of cracks in patients with vipadika |
10 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
12/06/2023 |
| 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="2"
Months="0"
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
|
This study is randomised comparative clinical study to evaluate the efficacy of gandhakadhya malahara over sarjarasadi lepa along with arogyavardhini vati in the management of vipadika with special reference to palmo-plantar psoriasis that will be conducted in BLDEAs AVS ayurveda mahavidyalaya hospital and research centre vijayapur 586109 karnataka.
|