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临床试验/CTRI/2025/07/091684
CTRI/2025/07/091684尚未招募3 期

PHARMACOGNOSTICAL AND CLINICAL STUDY TO EVALUATE THE EFFECT OF ZIZIPHUS RUGOSA .LAM BARK (KOTTEMULLU) IN MUKHAPAKA W.S.R TO APHTHOUS ULCER

Manjushree1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月26日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Assessment will be done after 1 week to check symptoms of mouth ulcer reduced. Such as redness pain of mouthulcer

研究概览

简要总结

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

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients diagnosed with Apthous ulcer.
  • Patients between the age group of 18-60 years of age.

排除标准

  • a.Known cases of carcinoma.
  • b.Other inflammatory conditions of the oral cavity.
  • c.Any other systemic conditions interfere with the treatment.

结局指标

主要结局

Assessment will be done after 1 week to check symptoms of mouth ulcer reduced. Such as redness pain of mouthulcer

时间窗: 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

Follow up will be done after 2 weeks

时间窗: 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

a. Subjective parameters– b. Objective ( sphota/vrana) parameters -

时间窗: 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

Toda/ Severe pain Varna/ Colour

时间窗: 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

Gurutva/ Stiffness, inflammation. Sankhya/ Number

时间窗: 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

Daha/ Burning sensation Sthana/ Site

时间窗: 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

次要结局

  • Assessment for recurrence after 15 days(Recurrence time after 15 days)

研究者

发起方
Manjushree
申办方类型
Other [manjushree]
责任方
Principal Investigator
主要研究者

Dr Mohammed faisal

SDMCA UDUPI

研究点 (1)

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