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CTRI Number  CTRI/2025/11/097141 [Registered on: 10/11/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Series 
Study Design  Other 
Public Title of Study   Ayurvedic Management to reduce the disturbance of seeing black spots in front of the visual field. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishna Kumar V 
Designation  Reserach Officer(Ayurveda) 
Affiliation  National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy 
Address  OPD-No-4, Hospital Block, National Ayurveda Research Institute for Panchakarma , Cheruthuruthy, Thrissur, Kerala

Thrissur
KERALA
679531
India 
Phone  07306892140  
Fax    
Email  drkkempran@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Krishna Kumar V 
Designation  Reserach Officer(Ayurveda) 
Affiliation  National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy 
Address  OPD-No-4, Hospital Block, National Ayurveda Research Institute for Panchakarma , Cheruthuruthy, Thrissur, Kerala


KERALA
679531
India 
Phone  07306892140  
Fax    
Email  drkkempran@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Krishna Kumar V 
Designation  Reserach Officer(Ayurveda) 
Affiliation  National Ayurveda Research Institute fort Panchakrma , Cheruthuruthy 
Address  OPD-No-4, Hospital Block, National Ayurveda Research Institute for Panchakarma , Cheruthuruthy, Thrissur, Kerala


KERALA
679531
India 
Phone  07306892140  
Fax    
Email  drkkempran@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences 
Address  61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 
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 
Krishna Kumar V  National Ayurveda Research Institute for Panchakarma  OPD-NO-4, Hopsital Block, National Ayurveda Research Institute for Panchakarma , Cheruthuruthy-679531, Thrissur, Kerala
Thrissur
KERALA 
07306892140

drkkempran@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, NARIP, CHERUTHURUTHY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H433||Other vitreous opacities. Ayurveda Condition: TIMIRAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The average change from baseline in the Floater Disturbance Questionnaire score compared to baseline at the end of 90 days.  The average change from baseline in the Floater Disturbance Questionnaire score compared to baseline at the end of 90 days. 
 
Secondary Outcome  
Outcome  TimePoints 
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.
 
90 days 
Participant-reported adherence, defined as taking or not taking study medication.
 
90 days 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   N/A 
Date of First Enrollment (India)   20/11/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
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. 

 
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