A clinical tria on human volunteers

A clinical trial is a research study in human volunteers to answer specific questions. It is a practical implication of theoretical knowledge. It helps in, to understand drug action, to search causative factor, a better understanding of pathogenesis, to check the efficacy of Ayurvedic medicines and a powerful tool to establish the validation of a drug or a procedure. In the present study, a clinical trial has been conducted in an attempt to fulfill the following objectives.

Objectives of research

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

Materials and methods

For the clinical study, patients attending the OPD & IPD of the department of Shalakya Tantra of AIIA Hospital with the signs &symptoms of Abhishyanda (Acute conjunctivitis) would be selected randomly irrespective of their sex, habit, religion, etc. Total of 33 patients were recruited for the study. The assessment of clinical study has been done on the basis of a special performance of scoring pattern and analyzed statistically with the help of T value.

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

Inclusion criteria

• Patients of either sex aged up to 7-30 years.
• Patients presenting with signs and symptoms of Abhishyanda ( acute conjunctivitis)
•  Patients who are willing and able to participate in the study.

Exclusion criteria

•  Chronic or subacute conjunctivitis
• Blepharitis
•  Trachoma
• Drugs

Hence, it is a Single-Arm clinical study it is further divided into 2groups to see the Comparative effect of different Thickness at Baseline and after treatment . 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 done after trying the Bidalaka with powder of different particle size from three sieves of 60, 80, 100 number . Thickness of Bidalaka , which was mentioned in the classics, is to be converted into metric scale. Proportion of liquid & quantity of the powder required for the ideal process of Bidalaka was measured to standardize the procedure & compliance on the healthy volunteers (who were not suffering from the eye disease) was noted.

Standardization Units

• Particle size-Particle size from three sieves of 60,80 & 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& difference in observation were noted.
•  Quantity of the powder required- It was taken in the amount that sufficient to cover the area around the eyeball except the eyelashes & the amount was measured in standard units.
•  The proportion of Liquid- It was taken in the amount that sufficient to mix the powders & the amount was measured in standard units.
• The thickness of Bidalak- According to classics there are 3 types 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 becomes converted into 5mm. Likewise medium thickness 6.5mm & maximum thickness 10mm & difference observed in all the thickness was noted.

Retention time-

It was not kept as fixed. Healthy volunteers were instructed to keep it before it was drying & that was noted.

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

Poorva karma

• The procedure was performed only in the morning & evening.
•  It was carried out in a neat, quiet & well-illuminated room where there was no entry of air or sunlight.
• The patient was kept in supine position.
• Eyes were cleaned with cotton soaked in lukewarm water.

Pradhana karma

• The medicaments should be applied as that of a leap over the closed eyes excluding the eyes lashes until it becomes dry
• Then gently removes the applied medications with the help of a gauze piece dipped in lukewarm water.
• Care should be taken that the particles should not fall inside the eye during removal of the paste

Pashchat karma

• Wipe the eyes & surrounding area with cotton comfortably without putting much 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 on slit-lamp examination

The following were the screening and diagnostic criteria:

Congestion

1. No Congestion
2. Mild occasional congestion with a clear pattern of blood vessels
3. Moderate intermittent congestion with a clear pattern of blood vessels
4. Moderate congestion with the disturbed patterned of blood vessels
5. Severe Velvety conjunctiva with loss of pattern of blood vessels

Conjunctival follicles

1. No follicles
2. very mild(follicle present only in nasal &temporal side of tarsal conjunctiva
3. mild(follicle present in full tarsal plate)
4. moderate( follicle present in upper tarsal plate & lower fornix)
5. severe ( follicle present in big size like in VKC & GPC)

Lid swelling

1. no swelling
2. puffy lids with discrete mild chemosis visible 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 very mild (visual analogue score 1-2)
3. Intermittently present and mild (visual analogue score 2-3)
4. Frequently present and moderate-not disturbing the routine work(visual