“Pharmacognostico-Clinical study to evaluate the efficacy of Saireyaka patra lepa (Barleria prionitis Linn) in Palitya”

Research Design

1.     Study Design: It will bePharmacognostical, open label, single arm, clinical trial.

2.     Sampling method: Randomized sampling method.

3.     Sample Size: 30 subjects of palitya

4.     Selection Criteria: Diagnosed subjects of palitya will be selected on the basis of simple randomized sampling procedure by preparing special case proforma.

5.     **Duration:**Single application, wash after 2 hr.

6.     Grouping**:** Singlegroup

7.     DIAGNOSTIC PARAMETERS:

1.     SUBJECTIVE CRITERIA:

a)     Colour of hair

b)     Dry splitted hair

c)     Unctuous thick hairs

d)     Burning sensation of scalp

2.     OBJECTIVE CRITERIA:

a)     Random gray hair count in selected 1cm2 area of scalp

INCLUSION CRITERIA:

a)     The individuals having the age group between 18-40 years.

b)     The patient with least of gray hair in particular area or in wide spread in scalp.

EXCLUSION CRITERIA:

a)     Any kind of fungal or other infection of scalp

b)     Any major systemic disorder

c)     Other skin disorder like psoriasis, eczema, leukoderma.

**8.**INTERVENTION CHART:

Sr.no

Test drug

Part used

Route of administration

No. of patient

Dose

Base

duration

|1

Saireyaka

patra

lepa

30

q.s

water

Single application wash after 2hr.

9. WITHDRAWAL CRITERIA: The participants will be allowed to withdraw from the trial if there is any major ailment necessitating the institution of new modalities of treatment. The decision to withdraw a participant from the trial will be taken by the principal investigator on their will, with proper justification and formal information to the guide and the ethical committee within two working days.

10. DROP OUTS: An attempt will be made to record the reason for drop outs, if any during the clinical trial.

11. DRUG COMPLIANCE: If there is more than or equal to 80% compliance, the participant will be continued in the trial. The compliance will be assessed at each visit during the follow up by counting the number of gray hairs.

12. ADVERSE DRUG REACTION (ADR): A response which is noxious, unintended, and which will occur at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. (WHO1972). It will be characterized by the suspicion of a causal relationship between the drug and the occurrence, i.e., judged as being at least possibly related to treatment by the reporting or a reviewing health professional.

13. RECORDING AND REPORTING OF ADR**:** Any adverse event, observed during treatment period or during follow up visits will be clearly documented using ADR form (attached) and appropriate and timely management will be done consulting the physician associated in the trial. The investigating team will report the same to the pharmacovigilance cell at the earliest.

14. CONCOMITANT MEDICATION: Details of concurrent illness and medications consumed by participant registered under the trial will be recorded in case report form.

Registered individuals will be instructed to avoid the use of any other drugs on their own for any ailment and will be clearly instructed to consult the treating investigating physician for any symptom or complaint, or if they feel anything unusual. The investigating physician will record any medication (s) he/ she may prescribe to alleviate their concurrent ailments.

15. RESCUE MEDICATION: Care and precautions will be taken in procedure of application of saireyaka patra lepa.

In case of unintended circumstances, medication intended to relieve symptoms immediately to alleviate any emergency will be administered immediately under the guidance of physician associated in the trial.However, the same will be documented in appropriate column in the case record form.

16. FOLLOW UP: Subjective and objective parameters will be assessed before treatment and immediately after the treatment. Then follow up will be carried out after 15th and 30th day of treatment.

7.3) ASSESSMENT CRITERIA:

PARAMETERS:

SUBJECTIVE CRITERIA:

**1.**COLOUR OF HAIRS:

Colour of hair

Grade

|Black in colour

0

|Ash colour

1

|Coppery colour

2

|White colour

3

2. DRY SPLIT HAIR:

Feature

Grade

|Normal

0

|Dryness visible

1

|Dryness felt by touch

2

|Dryness felt with splitted hairs

3

        **3.**UNCTUOUS THICK HAIR:

Features

Grade

|Normal

0

|Unctuous visible

1

|Unctuous felt by touch

2

|Unctuous felt with splitted hairs

3

4. BURNINGSENSATION OF SCALP:

Features

Grade

|No burning sensation

0

|Mild (localized burning without disturbed sleep)

1

|Moderate (localised burning with disturbed sleep)

2

|Severe (burning all over the scalp with disturbed sleep)

3

OBJECTIVE CRITERIA:

**1.**RANDOM HAIR COUNT: One site of the scalp will be chosen where more gray hairs will be present. 1cm2 will be chosen from that site and number of gray hairs will be counted.

**Number
of gray hairs**

severity

Grade

|No gray hair

Normal

0

|1 to 10 gray hairs

Mild

1

|10 to 25 gray hairs

Moderate

2

|More than 25 gray hairs

Severe

3

 STATISTICAL****ANALYSIS: Statistical evaluation of the above parameters will be carried out by using student paired ‘t’ test in consultation with Biostatistician.