| CTRI Number |
CTRI/2025/07/091684 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Ayurveda |
| Study Design |
Single Arm Study |
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Public Title of Study
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PHARMACOGNOSTICAL study AND CLINICAL STUDY TO EVALUATE THE action OF ZIZIPHUS RUGOSA .LAM BARK (kottemullu) known as badara,in mouth ulcer
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Scientific Title of Study
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PHARMACOGNOSTICAL AND CLINICAL STUDY TO EVALUATE THE EFFECT OF ZIZIPHUS RUGOSA .LAM BARK (KOTTEMULLU) IN MUKHAPAKA W.S.R TO APHTHOUS ULCER
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| Trial Acronym |
NIL |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
Dr Mohammed faisal |
| Designation |
Associate professor |
| Affiliation |
SDMCA UDUPI |
| Address |
Dept of dravyaguna vijyana SDMCA UDUPI
Udupi
KARNATAKA
574118
India |
| Phone |
9663755897 |
| Fax |
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| Email |
drfaisalsaheb@gmail.com |
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Details of Contact Person
Scientific Query
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| Name |
Dr Mohammed faisal |
| Designation |
Associate professor |
| Affiliation |
SDMCA UDUPI |
| Address |
Department of Dravyaguna vijyana SDMCA UDUPI
Udupi
KARNATAKA
574118
India |
| Phone |
9844873282 |
| Fax |
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| Email |
drfaisalsaheb@gmail.com |
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Details of Contact Person
Public Query
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| Name |
Manjushree Sahu |
| Designation |
Student |
| Affiliation |
SDMCA UDUPI |
| Address |
Padmapani 319/a, tilak nagar gda layout
Gulbarga
KARNATAKA
585105
India |
| Phone |
09663755897 |
| Fax |
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| Email |
manjushreesahu1@gmail.com |
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Source of Monetary or Material Support
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| SDMCA UDUPI 574118 karnataka india |
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Primary Sponsor
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| Name |
Manjushree |
| Address |
Sdm college of ayurveda udupi 574118 karnataka india |
| Type of Sponsor |
Other [Manjushree] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrManjushree Sahu |
SDMCA UDUPI |
Department of Dravyaguna vijyana, Shri dharmasthala manjunatheshwara college of ayurveda udupi 574118 karnataka india
Udupi
KARNATAKA |
9663755897
manjushreesahu1@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical clearance committee human |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K120||Recurrent oral aphthae. Ayurveda Condition: MUKHAROGAH, |
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Intervention / Comparator Agent
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| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratisAraNam, प्रतिसारणम् | (Procedure Reference: Shalakya tantra, Procedure details: The quantity of fine powder used for Pratisrana will be based on individual size of ulcer and number of ulcers in the mouth for 20 minutes, followed by lukewarm water Gandusha.
This will be given twice in a day , for 7 Days
)
(1) Medicine Name: Zizphus rugosa, Reference: Folklore , Route: Oral, Dosage Form: Kalka/ Paste, Dose: 5(g), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | pratisAraNam, प्रतिसारणम् | (Procedure Reference: Shalakya tantra, Procedure details: The quantity of powder used for pratisarana will be based on size & number of ulcer. Its applied n kept for 2 to 3min & the followed by gandusha for a span of 1 week)
(1) Medicine Name: Ziziphus rugosa , Reference: Folklore, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(mg), Frequency: bd, Duration: 7 Days |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients diagnosed with Apthous ulcer.
b. Patients between the age group of 18-60 years of age.
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| ExclusionCriteria |
| Details |
a.Known cases of carcinoma.
b.Other inflammatory conditions of the oral cavity.
c.Any other systemic conditions interfere with the treatment.
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Method of Generating Random Sequence
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Method of Concealment
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Blinding/Masking
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Primary Outcome
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| Outcome |
TimePoints |
Assessment will be done after 1 week to check symptoms of mouth ulcer reduced. Such as redness pain of mouthulcer
Follow up will be done after 2 weeks
a. Subjective parameters– b. Objective ( sphota/vrana) parameters -
Toda/ Severe pain Varna/ Colour
Gurutva/ Stiffness, inflammation. Sankhya/ Number
Daha/ Burning sensation Sthana/ Site
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Assessment will be done after 1 week
Follow up will be done after 2 weeks
a. Subjective parameters– b. Objective ( sphota/vrana) parameters -
Toda/ Severe pain Varna/ Colour
Gurutva/ Stiffness, inflammation. Sankhya/ Number
Daha/ Burning sensation Sthana/ Site
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Secondary Outcome
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| Outcome |
TimePoints |
| Assessment for recurrence after 15 days |
Recurrence time after 15 days |
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Target Sample Size
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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" |
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Phase of Trial
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Phase 3 |
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Date of First Enrollment (India)
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26/07/2025 |
| 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 |
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Estimated Duration of Trial
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Years="1"
Months="1"
Days="1" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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N/A |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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In Mukhapaka, the aggravated Vatadi Doshas afflict the mukha to produce Paka and Vrana. The common symptoms includes the Sphutana or Vadanasya Antarvrana (formation of ulcers in the mouth), Toda (severe pain), Daha (burning sensation) . This condition can be co-related to Aphthous ulcer or ulcerative stomatitis. It may occur in any part of the mouth.1 Aphthous ulcer is one of the most common ulcerative disease associated mainly with the oral mucosa, characterized by the extremely painful, recurring solitary, multiple ulcers in the upper throat and oral cavity. This is the most prevailing oral ulcerative disorder affecting up to 10- 20% of our inhabitants and recurrence rate of 3 months in 50% of the population. These are quite painful; may lead to difficulty in eating, speaking and swallowing.2 Mouth ulcer is most commonly seen in individuals who are under the pressure of physical or emotional stress, trauma during dental procedure, hormonal changes, aggressive tooth cleaning, eating more spicy food, biting of tongue or cheek accidentally and in deficiency of vitamin B12, folic acid. Prolonged ulceration may lead to Aphthous ulcer. 3 Ziziphus rugosa Lam.is one of the wild variety plants belonging to the familyRhamnaceae, is considered one among the verities of Laghu Badara.4 The phytochemical analysis showed the presence of the chemical constituents such as cyclopeptide alkaloids, triterpene, saponins isolated from the bark possess the antimicrobial property. The pharmacological studies revealed that Ziziphus rugosa Lam. possess antidiabetic, antioxidant, anti-inflammatory, analgesic, anti-cancer, antimicrobial and many other effects.5 It is considered as a ‘Kottemullu’ in southern Karnataka6 . In the Traditional natives of Tamilnadu, Karnataka, Western Ghats, people mainly use this dried stem bark as astringent for Mouth ulcer. They also use the bark of this plant for the treatment of Skin disease, Cough, diarrhea, hypotension.7 Currently, the treatment for the Aphthous ulcer being very limited, the present clinical study is designed to evaluate the efficacy of Ziziphus rugosa lam. bark Choorna in the Mukha Paka, w.s.r to Apthous ulcer .It will be an open study with pre test and post test design where in minimum 30 patients diagnosed with Mukha paka irrespective of their gender, caste and religion will be selected based on diagnostic and inclusion criteria.The quantity of fine powder used for Pratisrana will be based on individual size of ulcer and number of ulcers in the mouth for 20 minutes, followed by lukewarm water Gandusha. This will be given twice in a day , for 7 Days
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