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临床试验/CTRI/2025/11/097141
CTRI/2025/11/097141尚未招募不适用

Clinical outcomes of oral administration of Ayurvedic polyherbal formulation (Mahatriphala ghrita) for 90 days compared to the baseline in patients( 50-70 years) with Vitreous floaters at a research hospital in Kerala: A case series

Central Council for Research in Ayurvedic Sciences1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
10
试验地点
1
主要终点
The average change from baseline in the Floater Disturbance Questionnaire score compared to baseline at the end of 90 days.

研究概览

简要总结

Vitreous floaters are prevalent in 76 percent of the general population. Floaters are resulted from vitreous degeneration caused due to oxidative stress. It is perceived by patients as mobile spots, threads, or cobweb-like structures in the visual field. Primary vitreous floaters are those arising from structures endogenous to the vitreous and attributed to vitreous degeneration, posterior vitreous detachment (PVD), or pathological myopia. Secondary floaters are due to inflammation, hemorrhage and asteroid hyalosis. In most cases of primary floaters, symptoms may subside in three months. However, in some others symptoms may not subside and greatly affect the patient’s vision. It may even cause substantial level of psychological distress. In contemporary biomedical practice, management strategies depend on the underlying etiology. In most cases of floaters,while invasive procedures like pars plana vitrectomy or Nd:YAG laser vitreolysis may be employed in severe cases of persistent floaters, there remains no widely accepted or effective treatment for less severe cases. The conventional treatment mostly offered to such case is watchful waiting, after ophthalmologists have successfully ruled out the possibilities of retinal complications after the onset of floaters. In that, patients are only monitored after they have been either reassured that their floaters will resolve with time and counseled to adapt to their new visual experience. This therapeutic gap presents an opportunity to evaluate Ayurvedic interventions for their potential to produce meaningful, patient-perceived improvements in floater symptoms and vision-related quality of life.In Ayurvedic literature, the condition in which a patient perceives floaters is described as Dvitiya Patala Dosa (a disorder affecting the second ocular layer), classified under the National AYUSH Morbidity Code HG-1.2.A case report has documented that oral administration of an Ayurvedic polyherbal formulation (triphala yashti churna) for a duration of 90 days resulted in 50 % improvement of floater symptoms and is safe. It is an ayurvedic polyherbal formulation containing 5 gm of triphala churna (powder of Terminalia chebula Retz., Terminalia bellerica Gaertn., and Emblica officinalis Gaertn.,) and 2 gm of yashtimadhu churna (Glycerrhiza glabra Linn.). The formulation will be administered with 10 ml of Mahatriphala ghrita which is indicated for general wellbeing of ocular structures. Despite encouraging anecdotal and observational reports, robust clinical evidence validating the efficacy of Ayurvedic management for vitreous floaters remains scarce.

To address this evidence gap, the present study proposes  a case series to determine the clinical outcomes of oral administration of Mahatriphala Ghrita for 90 days compared to baseline, in patients (50-70 years) with vitreous floaters, at an ayurvedic research hospital in Kerala.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Participants presenting with symptomatic vitreous floaters persisting for more than three months.
  • They should have a clear ocular media to allow a clear view of the vitreous.

排除标准

  • Presence of vitreous hemorrhage, asteroid hyalosis Opacification of lens, cornea or vitreous.
  • Retinal diseases (e.g., Pathological myopia, retinal breaks or detachments, age-related macular degeneration, diabetic retinopathy, and branch retinal vein occlusion) Patients with Aspartate Amino Transferase (AST) and or Alanine Amino Transferase (ALT) levels greater than 2 times the upper normal limit, or Patients with S.
  • Creatinine greater than the upper limits of the normal.
  • History of malignancy within five years.
  • History of hypersensitivity to the trial drug or any of its ingredients.
  • Continuing addiction to smoking and usage of tobacco in any form Individuals simultaneously or previously (within 30 days before the investigation starts) participated in a clinical investigation using experimental drugs or devices.

结局指标

主要结局

The average change from baseline in the Floater Disturbance Questionnaire score compared to baseline at the end of 90 days.

时间窗: The average change from baseline in the Floater Disturbance Questionnaire score compared to baseline at the end of 90 days.

次要结局

  • Participant-reported adherence, defined as taking or not taking study medication.
  • The average change from baseline in the NEI VFQ-25 score compared to baseline at the end of 90 days.(90 days)
  • The average changes from baseline in the LFT and KFT, values compared to baseline at the end of 90 days.

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Krishna Kumar V

National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy

研究点 (1)

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