A clinical tria on human volunteers

A medical trial is a research study in human volunteers to answer particular questions. It is a practical implication of theoretical data. It helps in, to grasp drug motion, to go looking causative factor, a better understanding of pathogenesis, to verify the efficacy of Ayurvedic medicines and a strong device to establish the validation of a drug or a procedure. In the current examine, a medical trial has been performed in an attempt to meet the following aims.

Objectives of research

  • Standardization of Bidalakaprocedure.
  • To evaluate the efficacy of Saindhavadi Bidalakain Abhishayanda (acute conjunctivitis).

Materials and methods

For the scientific research, patients attending the OPD & IPD of the division of Shalakya Tantra of AIIA Hospital with the signs &signs of Abhishyanda (Acute conjunctivitis) could be selected randomly regardless of their sex, behavior, religion, and so on. Total of 33 sufferers had been recruited for the research. The evaluation of scientific research has been carried out on the idea of a special efficiency of scoring pattern and analyzed statistically with the assistance of T value.

Informed consent was taken from all the registered sufferers for the trial.

Inclusion criteria

  • Patients of both sex aged as a lot as 7-30 years.
  • Patients presenting with signs and symptoms of Abhishyanda ( acute conjunctivitis)
  •  Patients who are willing and in a place to take part within the research.

Exclusion criteria

  •  Chronic or subacute conjunctivitis
  • Blepharitis
  •  Trachoma
  • Drugs

Hence, it is a Single-Arm scientific study it’s additional divided into 2groups to see the Comparative effect of various Thickness at Baseline and after therapy . So in Right eye-6.

5mm thickness. Left eye- 5mm thickness

The raw drug was procured as per the policy of AIIA,New Delhi . Then standardization was carried out after trying the Bidalaka with powder of various particle measurement from three sieves of 60, eighty, a hundred quantity . Thickness of Bidalaka , which was mentioned in the classics, is to be converted into metric scale. Proportion of liquid & amount of the powder required for the perfect process of Bidalaka was measured to standardize the process & compliance on the healthy volunteers (who weren’t suffering from the eye disease) was famous.

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Standardization Units

  • Particle size-Particle size from three sieves of 60,eighty & 100 number were taken in a ratio of 5:2:1 1:5:20 1.50:1:5.50 respectively,
  • According to different pharma company& distinction in observation were famous.
  •  Quantity of the powder required- It was taken within the quantity that sufficient to cover the world around the eyeball besides the eyelashes & the quantity was measured in normal units.
  •  The proportion of Liquid- It was taken within the quantity that sufficient to combine the powders & the amount was measured in normal units.
  • The thickness of Bidalak- According to classics there are 3 kinds of thickness i.e- Lowest thickness – 1/4 the angular,

Medium thickness – 1/3 rd angular & Maximum thickness – angular

According to A.P.I- 1Angula-20mm.nSo the lowest thickness turns into transformed into 5mm. Likewise medium thickness 6.5mm & most thickness 10mm & difference noticed in all of the thickness was noted.

Retention time-

It was not kept as fixed. Healthy volunteers had been instructed to keep it earlier than it was drying & that was noted.

Saindhavadi Bidalak was carried out as described in the classics & observation was recorded & analyzed.

Poorva karma

  • The process was carried out only within the morning & evening.
  •  It was carried out in a neat, quiet & well-illuminated room where there was no entry of air or daylight.
  • The patient was kept in supine place.
  • Eyes had been cleaned with cotton soaked in lukewarm water.

Pradhana karma

  • The medicaments must be utilized as that of a leap over the closed eyes excluding the eyes lashes until it turns into dry
  • Then gently removes the applied medications with the assistance of a gauze piece dipped in lukewarm water.
  • Care must be taken that the particles shouldn’t fall inside the eye throughout removal of the paste

Pashchat karma

  • Wipe the eyes & surrounding space with cotton comfortably with out putting a lot pressure
  • Put a cotton pad/eye pad & gently tied with the bandage cloth usually for 10 minutes to 15 minutes.

Criteria for diagnosis

Objective -Findings based mostly on slit-lamp examination

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The following had been the screening and diagnostic criteria:

Congestion
  1. No Congestion
  2. Mild occasional congestion with a transparent sample of blood vessels
  3. Moderate intermittent congestion with a transparent pattern of blood vessels
  4. Moderate congestion with the disturbed patterned of blood vessels
  5. Severe Velvety conjunctiva with lack of sample of blood vessels
Conjunctival follicles
  1. No follicles
  2. very mild(follicle current solely in nasal &temporal aspect of tarsal conjunctiva
  3. mild(follicle current in full tarsal plate)
  4. moderate( follicle present in upper tarsal plate & lower fornix)
  5. severe ( follicle present in huge dimension like in VKC & GPC)
Lid swelling
  1. no swelling
  2. puffy lids with discrete gentle chemosis seen on slit-lamp examination
  3. puffy lids with discrete mild chemosis visible on torchlight
  4. Swelling of lids visibly evident chemosis
  5. Swollen eyelids /ballooning of conjunctiva

Subjective symptom were assessed with the help of following scoring pattern

Pricking pain
  1. Absent/no pain
  2. Occasionally present and really gentle (visual analogue rating 1-2)
  3. Intermittently present and gentle (visual analogue rating 2-3)
  4. Frequently current and moderate-not disturbing the routine work(visual
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