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临床试验/CTRI/2025/10/095687
CTRI/2025/10/095687尚未招募2 期

Clinical Evaluation of Dugdhikadi Ghrita Per Rectal Instillation in Raktarsha (1st and 2nd Degree Bleeding Piles)

Aishwarya Uppal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月25日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Relief in Subjective Parameters :

研究概览

简要总结

This is an open randomized prospective study to evaluate the effect of Dugdhikadi Ghrita in Raktarsha for the age group between 18 years to 60 years for duration of 15 days. It will be clinical study of 30 patients suffering from Raktarsha. Patient will randomly selected irrespective of their gender, race, religion, occupation. This clinical study will be conducted with aims and objective to provide better, safe and effective management to the patient of Raktarsha. Total 30 patients will be registered for this study from the OPD/ IPD of surgery department of Uttarakhand Ayurveda University, Quadra Institute of Ayurveda Roorkee and other hospitals. A detailed proforma will be prepared on the basis of Ayurvedic text and allied science. The patient will be registered on this proforma and scoring of different clinical features will be done on the assessment criteria. The diagnosis is done on the basis of Raktarsha Lakshana mentioned in Ayurvedic classical textbooks. The patients were assessed on the basis of subjective and objective parameters before and after treatment. The observation of patients will be done before, during and after completion of trial. Little addition or exclusion may be done as per necessity of the study.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

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 with the Signs and symptoms of Raktarsha such as Raktasrava (Bleeding per rectum), Kandu (itching), Vibanda (Constipation), Daha (Burning sensation), Guda Vedana (Pain).
  • Patients between the age group of 18-60 years.
  • The patient having complaints of 1st and 2nd degree bleeding piles.
  • Patients with controlled DM and HTN.
  • Patients willing to undergo trail and ready to give informed and written consent.

排除标准

  • Patient below the age of 18 years and above the age of 60 years.
  • Patient who have HB less than 8 gm%.
  • Third and fourth degree prolapsed intero-external piles.
  • Known case of tuberculosis.
  • Patient suffering from severe systemic disorders such as HIV, Ulcerative colitis, Crohn’s disease, carcinoma of rectum and any hereditary bleeding disorder will be excluded from this study.
  • Patients on Thrombolytic drugs.
  • Patient with uncontrolled DM and HTN.
  • The associated condition like Fistula-in-ano, Fissure-in-ano will be excluded from this study.
  • Patient who are not ready to sign written informed consent.

结局指标

主要结局

Relief in Subjective Parameters :

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

1. Raktsrava (Bleeding per anum)

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

2. Frequency of bleeding per anum

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

3. Vibanda (Constipation)

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

4. Guda Vedana (Pain in anal region)

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

5. Prolapsed pile mass per rectum

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

6. Daha (Burning Sensation)

时间窗: Assessment will be done on 0 day (Before Treatment), 7th day (After treatment), 15th day (After treatment), 1st follow-up (After 15 days), 2nd follow-up (15 days after 1st follow-up).

次要结局

  • Relief in Objective Criteria:(1. Site)

研究者

发起方
Aishwarya Uppal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Aishwarya Uppal

Quadra Institute of Ayurveda and Hospital Roorkee Haridwar

研究点 (1)

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