| CTRI Number |
CTRI/2025/02/081302 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study on the effectiveness of Ayursoft lipbalm with and without Sarjarasadi nasya for treating cracked lips |
|
Scientific Title of Study
|
Comparative clinical study to assess the efficacy of Ayursoft lipbalm and Sarjarasadi nasya with Ayursoft lipbalm in vataja oshtha prakopa w.s.r. to cracked lips. |
| 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. Tanmayee Bhoir |
| Designation |
PG Scholar |
| Affiliation |
D Y Patil, School of Ayurveda,Nerul,Navi Mumbai |
| Address |
D Y Patil,School of Ayurveda First Floor OPD No. 05, Department of Shalakya Tantra,
D Y Patil Vidyanagar, Sector 07, Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9021700905 |
| Fax |
|
| Email |
tanmayeebhoir24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Mugdha Sawle |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil, School of Ayurveda,Nerul,Navi Mumbai |
| Address |
D Y Patil School of Ayurveda First Floor OPD No. 05, Department of Shalakya Tantra,
D Y Patil Vidyanagar, Sector 07, Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9892079391 |
| Fax |
|
| Email |
mugdha.sawle@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Mugdha Sawle |
| Designation |
Associate Professor |
| Affiliation |
D Y Patil, School of Ayurveda,Nerul,Navi Mumbai |
| Address |
D Y Patil School of Ayurveda First Floor OPD No. 05, Department of Shalakya Tantra,
D Y Patil Vidyanagar, Sector 07, Nerul,Navi Mumbai.
Thane
MAHARASHTRA
400706
India |
| Phone |
9892079391 |
| Fax |
|
| Email |
mugdha.sawle@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D Y PATIL, School of Ayurveda and Hospital, D Y Patil Vidyanagar, Sector 07, Nerul,Navi Mumbai, 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Tanmayee Bhoir |
| Address |
D Y Patil, School of Ayurveda and Hospital, D Y Patil Vidyanagar, Sector 07, Nerul, Navi Mumbai, 400706 |
| 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 |
| Dr Tanmayee Bhoir |
D Y Patil Ayurvedic Hospital, Navi Mumbai |
Department of Shalakya Tantra,First Floor, OPD No.-05
Thane
MAHARASHTRA |
9021700905
tanmayeebhoir24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional 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: VATAJA-OSHTHAPRAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: AYURSOFT LIPBALM, Reference: BHAISHAJYA RATNAVALI, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 4(drops), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: SUSHRUTA CHIKITSA, Procedure details: PRATIMARSHA NASYA ( 2 DROPS IN EACH NOSTRIL)
2 CYCLES OF 7 DAYS WITH GAP OF 14 DAYS
DURATION-28 DAYS)
(1) Medicine Name: SARJARASADI NASYA, Reference: SUSHRUT CHIKITSA, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients of age group above 18 and below 50 years will be selected for the study.
2)Patient who is willing and able to participate in the study.
3)Patients presenting with minimum 03 signs and symptoms of Cracked Lips and lakshana of Vataja Oshtha Prakopa as described in subjective parameters.
4)Patient irrespective of sex, socio-economic status, religion and occupation will be selected.
5)Patients with gradation from 0-6 in photonumeric lip dryness grading scale as described in objective parameters will be selected.
|
|
| ExclusionCriteria |
| Details |
1)Age group less than 18 years and more than 50 years
2)Patient who is not willing for participate in this study.
3)Patients with diseases such as mucocele of lip, tumour of lip, oral submucosal fibrosis, stomatitis, carcinoma of lips and immunocompromised conditions.
4)Patients who has habit of smoking, tobacco chewing and patients diagnosed with Diabetes Mellitus.
5)Patients with gradation from 7-8 in photonumeric lip dryness grading scale as described in objective parameters will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of clinical symptoms- Rough lips, dry lips, blackish discolouration of lips, Severe pain in lips,cracks in lips and fissures formed in lips |
28 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of clinical symptoms- Rough lips, dry lips, blackish discolouration of lips, severe pain in lips,cracks in lips & fissures formed in lips |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/03/2025 |
| 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
|
TITLE COMPARATIVE CLINICAL STUDY TO ASSESS THE EFFICACY OF AYURSOFT LIPBALM AND SARJARASADI NASYA WITH AYURSOFT LIPBALM IN VATAJA OSHTHA PRAKOP W.S.R. TO CRACKED LIPS. The effectiveness of Ayursoft lip balm alone vs. the combination of Ayursoft lipbalm and Sarjarasadi Nasya therapy in managing vataja oshtha prakop(cracked lips). Vataja oshtha prakop, characterized by dryness, cracking, and pain in the lips, is often caused by factors like cold weather, pollution and poor hydration. Ayursoft lipbalm provides deep moisturization, while sarjarasadi nasya offers therapeutic benefits through nasal administration of medicated oil. The study involves two groups of 30 patients each, with Group A receiving only the lip balm and Group B receiving both treatments over 28 day, Outcomes will assist the reduction in symptoms such as dryness, cracking and irritation, aiming to establish a more effective management approach for cracked lips through ayurveda. |