| CTRI Number |
CTRI/2024/10/075738 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
PUBLIC TITLE OF STUDYTO EVALUATE THE EFFICACY OF
MANJISTHA LEPA WITH YASHTIMADHU CHURNA INTERNALLY IN THE MANAGEMENT OF
VYANG VYADHI |
|
Scientific Title of Study
|
RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF
MANJISTHA LEPA WITH YASHTIMADHU CHURNA INTERNALLY IN THE MANAGEMENT OF
VYANG VYADHI |
| 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 Nilophar Iqbal Mulani |
| Designation |
Pg scholar |
| Affiliation |
Yashwant ayurvedic medical college kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur 416114
India
Kayachikitsa department
3rd floor 2nd room no
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7083838573 |
| Fax |
|
| Email |
aftabmulani99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Nilophar Iqbal Mulani |
| Designation |
Pg scholar |
| Affiliation |
Yashwant ayurvedic medical college kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur
MAHARASHTRA
416114
India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9860073109 |
| Fax |
|
| Email |
nilopharmulani1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVasundhara Borakhade |
| Designation |
MD Phd |
| Affiliation |
Yashwant ayurvedic medical college kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research
Centre Kodoli Tal Panhala Dist Kolhapur
Kayachikitsa department 3rd floor 2nd room no
MAHARASHTRA
416114
India
MAHARASHTRA
416114
India |
| Phone |
919822885710 |
| Fax |
|
| Email |
vasudha.borakhade@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G Phytopharma Address B-53D /21 , MIDC Gokul shirgaon, S G phytopharma
Pharmaceuticals ltd Kolhapur 416237 |
|
|
Primary Sponsor
|
| Name |
Dr.Nilophar Iqbal Mulani |
| Address |
OPD No 17 Kayachikitsa Department Second floor Yashwant
Ayurvedic College Post Graduate Training and Research Centre
Kodoli Tal Panhala Dist Kolhapur MAHARASHTRA 416114 India |
| 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 |
| DrVasudha borakhade |
Yashwant ayurvedic medical college kodoli |
Yashwant Ayurvedic
College Post Graduate
Training and Research
Centre Kodoli OPD No
17 kayachikitsa
Department Second
Floor Yashwant
Ayurvedic College Post
Graduate Training and
Research Centre Kodoli
Tal Panhala Dist
Kolhapur Kolhapur
MAHARASHTRA
416114 India
Kolhapur
MAHARASHTRA
Kolhapur
MAHARASHTRA |
9822885710
vasudha.borakhade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee Yashwant Ayurvedic College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L814||Other melanin hyperpigmentation. Ayurveda Condition: VYANGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhavprakash madhyam khand , Procedure details: Take churna as per requirement mix with madh apply twice a day bid for 20 min for 30days)
(1) Medicine Name: Manjistha lepa , Reference: Bhavprakash madhyam khand , Route: Topical, Dosage Form: Lepa Churna, Dose: 1(g), Frequency: bd, Duration: 30 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu churna, Reference: Bhavprakash madhyam , Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with sign and symptoms of vyanga vyadhi
kandu,osha,shyava varna,parushata,number of mandal, mandal size |
|
| ExclusionCriteria |
| Details |
Person suffering from any infective or contagious skin disease or
under medication with antibiotics antifungal and steroids |
|
|
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 |
To study the efficacy of Manjistha lepa with
Yashtimadhu churna internally in vyanga vyadhi |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the change in shyava varnata on face
To the change in size of mandal
To study bahiparimarjan chikitsa and lepa
kalpana in various literature
To study vyanga disease in detail |
30 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/11/2024 |
| 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
|
My title is RANDOMISED OPEN CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF MANJISTHA LEPA WITH YASHTIMADHU CHURNA INTERNALLY IN THE MANAGEMENT OF VYANG VYADHI .Included the patients with classical signs and symptoms of vyanga vyadhi kandu,osha,shyava varna,parushata,number of mandal,mandal size.Treatment given Manjistha lepa twice in a day for 20 min for 30 days and Yashtimadhu churna twice in a days for 30 days internally in vyanga vyadhi.To study the change in sign and symptoms of vyanga vyadhi. |