CTRI

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CTRI Number

CTRI/2025/04/084806 [Registered on: 15/04/2025] Trial Registered Prospectively

Last Modified On:

30/07/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Other

Public Title of Study

Ayurvedic treatment of Oral Submucous Fibrosis (Unable to open mouth) with Madhupippalyadi Yoga Pratisarana (local application over gums lepa ),Nishadi Taila Kavala (garggle) with and without Rasayana Yoga (internally oral medicine)

Scientific Title of Study

Role of Madhupippalyadi Yoga Pratisarana, Nishadi Taila Kavala with and without Rasayana Yoga Orally in the management of Oral Submucous Fibrosis - An Open Labelled Randomized Comparative Clinical Trial

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Tamanna Kumari
Designation	M.S. Scholar
Affiliation	ITRA Jamnagar
Address	Department of Shalakya, fourth floor,institute building Gurudwara Road Opp. B division, ITRA Jamnagar,Gujarat Jamnagar GUJARAT 361008 India Jamnagar GUJARAT 361008 India
Phone	9009838554
Fax
Email	tanurajawat671999@gmail.com

Details of Contact Person
Scientific Query

Name	Prof Dr D B Vaghela
Designation	Professor , HOD
Affiliation	ITRA Jamnagar
Address	4th floor, Department of Shalakya Tantra, Institute of Teaching and Research in Ayurveda, Jamnagar Jamnagar GUJARAT 361008 India Jamnagar GUJARAT 361008 India Jamnagar GUJARAT 361008 India
Phone	9825407899
Fax
Email	drvaghela@rediffmail.com

Details of Contact Person
Public Query

Name	Prof Dr D B Vaghela
Designation	Professor , HOD
Affiliation	ITRA Jamnagar
Address	4th floor, Department of Shalakya Tantra, Institute of Teaching and Research in Ayurveda, Jamnagar Jamnagar GUJARAT 361008 India Jamnagar GUJARAT 361008 India Jamnagar GUJARAT 361008 India
Phone	9825407899
Fax
Email	drvaghela@rediffmail.com

Source of Monetary or Material Support

Institute of Teaching and Research in Ayurveda, Jamnagar

Primary Sponsor

Name	Institute of Teaching and Research in Ayurveda, Jamnagar
Address	Institute of Teaching and Research in Ayurveda, Opp City B division Police station, Gurudwara road, Jamnagar,Gujarat, 361008
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Tamanna Kumari	Institute of Teaching and Research in Ayurveda Hospital	Department of Shalakya, fourth floor,institute building Gurudwara Road Opp. B division, ITRA Jamnagar,Gujarat Jamnagar GUJARAT 361008 India Jamnagar GUJARAT	9009838554 tanurajawat671999@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:O\|\|Medical and Surgical. Ayurveda Condition: SARVASARA MUKHAROGAH, (2) ICD-10 Condition:O\|\|Medical and Surgical. Ayurveda Condition: OSMF,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Drug	Classical		(1) Medicine Name: Madhupippalyadi Yoga, Reference: Anubhuta, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Locally as Pratisarana (2) Medicine Name: Nishadi Taila, Reference: Bh Pra Chp 66/165 Mukhrogadhikar, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Locally as Kavala
2	Intervention Arm	Drug	Classical		(1) Medicine Name: Madhupippalyadi Yoga, Reference: Anubhuta, Route: Topical, Dosage Form: Lepa Churna, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Locally as Pratisarana (2) Medicine Name: Nishadi Taila, Reference: Bh Pra Chp 66/165 Mukhrogadhikar, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Locally as Kavala (3) Medicine Name: Rasayana Yoga, Reference: Anubhuta, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu And Ghrut), Additional Information: Internally as Churna Madhu and Ghrut in unequal quantity

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Age Group between 18- 60 year old 2.The patient having cinical signs and symptoms blanching and stiffness of oral mucosa , altered taste sensation,altered salivation, repeated vesicular eruption and ulceration on buccal mucosa , palate and pillars , burning sensation in mouth , intolerance to hot and spicy foods, difficulty in opening mouth 3.Interincisal distance of more than 15mm 4.Patient Having minimum two Clinical symptoms of Oral Submucous Fibrosis will be included 4.Primary symptom is Blanching and stiffness of oral mucosa along with any other symptoms of osmf

ExclusionCriteria

Details

1.Age less than 18-60 years
2.Extensive Fibrosis of oral mucosa severe trismus with an interincisal distance of less than 15mm
3.Disease most advanced with premalignant and malignant changes.
4.Oral manifestation of scleroderma.
5.Oral lichen planus.
6.Chronic debilitating conditions like DM, HTN.
7.Patients not willing to give up habits of gutkha, pan masala, mawa, tobacco, betel quid or betel nut chewing.
8.Pregnant women should be excluded.
9.The patients taking any other systemic drugs which can alter the result of study.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Efficacy of intervention on signs and symptoms of Oral Submucous Fibrosis (OSMF).	during the treatment period at baseline 8 Weeks

Secondary Outcome

Outcome	TimePoints
Improvement in the quality of life of the patient Assessment of recurrence of signs & symptoms of Oral Submucous Fibrosis (OSMF) during follow up period	During follow up period on 15th ,30th,45th & 60th day

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)

02/06/2025

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)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Open to Recruitment

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

The trial is randomized clinical trial to evaluate the efficacy of Madhupippalyadi Yoga Pratisarana, Nishadi Taila Kavala with and without Rasayana Yoga Orally in the management of Oral Submucous Fibrosis (OSMF). Total 30 patients will be enrolled in the study. Selected patients will be divided into two groups on the basis of computer generated randomization. In the study Madhupippalyadi Yoga Pratisarana 3gm. BD,Nishadi Taila 15ml BD locally as kavala will be given before meal with Rasayana Yoga 6gm BD before meal with sahpana of madhu and ghrut for 2 month . In another group only Madhupippalyadi Yoga Pratisaran 3gm. BD, Nishadi Taila 15ml BD locally as kavala will be given before meal without Rasayana Yoga for 2 months. Follow up will be carried out at 15 days interval for 2 month on routine medicine.