| CTRI Number |
CTRI/2024/11/077151 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| 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
|
This study will be perf iormed to understand the effect of prepared ayurvedic medicine (Navneet Madhu lepa and puran ghruta lepa) in vataj oshtharoga (lip disease) which includes symptoms like dryness, cracked lips, roughness, blackish lips. |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Navneet and Madhu lepa with puran ghruta lepa in vataj oshthaprakop . |
| 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 Nutan Sawant |
| Designation |
PG scholar |
| Affiliation |
PDEAs College Of Ayurved and Research centre |
| Address |
PDEAs College Of Ayurved and Research Centre 3rd floor shalakyatantra department sector 25 pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9082373028 |
| Fax |
|
| Email |
drnutansawant@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr chandana virkar |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College Of Ayurved and Research centre |
| Address |
PDEAs College Of Ayurved and Research Centre 3rd floor shalakyatantra department sector 25 pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Sawant |
| Designation |
PG scholar |
| Affiliation |
PDEAs College Of Ayurved and Research centre |
| Address |
PDEAs College Of Ayurved and Research Centre 3rd floor shalakyatantra department sector 25 pradhikaran Nigadi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9082373028 |
| Fax |
|
| Email |
drnutansawant@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre 3rd floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and researchg centre |
| Address |
PDEAs College of Ayurved and Research Centre 3rd floor shalakyatantra department sector no. 25 pradhikaran Nigadi Pune |
| Type of Sponsor |
Private medical college |
|
|
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 Nutan Narayan Sawant |
PDEAs college of Ayurved and research Centres Ayurved rugnalay |
sector no.27 shalakya OPD no. 122 pradhikaran , nigadi ,pune
Pune
MAHARASHTRA |
9082373028
drnutansawant@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:8||Other Procedures. Ayurveda Condition: OSHTHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Navaneet and madhu , Reference: Shastri N,Harit Samhita,chapter 64, shlok 3, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Puran ghruta , Reference: Mishra B , bhavprakash Nighantu, chapter 31, shlok 17 , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient showing minimum 3 sign symptoms of vataj oshtharoga as rough, dryness, immobile, blackish, severe painand cracked lips |
|
| ExclusionCriteria |
| Details |
Known case of mucocele of lips, severe dryness, tumors of lips. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of navaneet madhu lepa to reduce symptoms of vataj oshthaprakop viz rough, dryness, immobile, blackish, cracked lipsover period of 7 days for twice a day |
efficacy of navaneet madhu lepa to reduce symptoms of vataj oshthaprakop viz rough, dryness, immobile, blackish, cracked lipsover period of 7 days for twice a day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study any adverse effect of navaneet madhu lepa in vataj oshthaprakop over period of 7 days for twice a day |
During the 7 days of treatment assessment will be done |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
20/11/2024 |
| 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
|
Increased consciousness about one’s beauty and busy life schedule demands for the need of a safe,effective,short term,easy available and at the same time easily applicable remedy to maintain the lips. Thus navaneet and madhu lepa is selected for the present study to evaluate its role in management of vataj oshtharoga . As madhu having properties like vranashodhan, vranaropan, sukomaryakar and navaneeta having properties like atisnigdh, vatshamak, varnya (bha.pra.madhyam khand ) Since ghruta is having properties like vranashodhan, vranaropan, kantivardhak,snigdhguna it has been selected as control group for the comparative study with navaneet and madhu lepa. No previous work has done on navaneet and madhu lepa. Easy avaibility of all ingredients. So, it is planned to evaluate the efficacy of navaneet and madhu lepa.
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