| CTRI Number |
CTRI/2023/10/059180 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Sarjarasadi (Raal) Lepa in the managment of Vataj Oshtharoga (seasonal cracked lips) |
|
Scientific Title of Study
|
An exploratory clinical trial to study the effect of Sarjarasadi Lepa in Vataj Oshtharoga. |
| 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 Prajakta Shivaji Metkari |
| Designation |
Pg Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi Pune. |
| Address |
PDEAs College of Ayurved and Research Centre,3rd
floor,Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9130310928 |
| Fax |
|
| Email |
21praj54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,3rd
floor,Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandana Virkar |
| Designation |
Professor and HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,3rd
floor,Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi
MAHARASHTRA
411044
India |
| Phone |
9822199107 |
| Fax |
|
| Email |
drvirkarchandana@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,3rd
floor,Shalakyatantra Department, Sector no 25, Pradhikaran Nigdi |
| 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 Prajakta Shivaji Metkari |
Ayurved Rugnalya and Sterling Multi-speciality Hospital, Nigdi Pune |
Ayurved Rugnalya and
Sterling Multi-speciality
Hospital, Shalakyatantra
Department, OPD no
122 Sector no 27
Pradhikaran Nigdi Pune
Pune
MAHARASHTRA |
9130310928
21praj54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K130||Diseases of lips. Ayurveda Condition: OSHTHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarjarasadi Lepa, Reference: Yogratnakar Mukhrog Chikitsa Adhyay shlok no. 3, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 0(NA), Frequency: tds, 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 |
1) Patients showing minimum 3 signs and symptoms of vataj Oshatharoga like Karkasha (Rough), Parushta (Dryness), Sthabdhata (Immobile), Krushnavarni (Blackish), Tivraruja (Severe pain), Dalan (Cracked lip), Paripatan described as per
Ayurvedic Texts.
2) Patient of age group above 18 and below 60 years will be selected for the study.
3) Patients irrespective of sex, socio-economic status, religion and occupation will be selected. |
|
| ExclusionCriteria |
| Details |
1. Mucocele of lip
2. Severe dry lip
3. Tumour of lip
4. Carcinoma of lip |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Sarjasaradi lepa in Vataj Oshtharoga. |
7 days of study with 2 follows on the 4th and 8th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study adverse effect if any |
7 days of study with 2 follows on the 4th and 8th day |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
10/11/2023 |
| 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="0"
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
|
According to ayurveda Samhita, different acharaya have described
different number of oshthaj rog, sushutacharaya-8,
vaghbhatacharaya-11, sharangdharacharaya-11. Vataj oshtharog is
one of them. It is a sadhya roga. Karkasha (Rough), Parushta (Dryness), Sthabdhata (Immobile),
Krushnavarni (Blackish), Tivraruja (Severe pain), Dalan (Cracked lip),
Paripatan - these are symptoms of vataj oshtharog according to
Yogratnakar and Ashtanghrudaya.
In modern science we can corelate vataj oshtharog with chapping
of lips or seasonal cracked lips. Because dryness, redness, cracking
and itching are common symptoms seen in both vataj oshtharog and
chapping of lips.
In hot or cold weather as well as in dry wind, the keratin of the
vermilion zone loses its plasticity and hence the lip becomes scaly,
cracked and sore. Sarjaras having snigdha property which reduce dryness of lip
and it does vatashaman. Sarjaras is used as a base ingredient in all Lepa due to its
snigdha guna. Moisture of sarjaras is long lasting. Ingredient of sarjarasadi lepa are easily available. |