| 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
|
|
|
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
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H433||Other vitreous opacities. Ayurveda Condition: TIMIRAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
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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.
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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. |
|
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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
|
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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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