SOMNA CLINICAL TRIAL REPORT

Title of Study: A single centre, single blind, fixed dosage, randomized, phase II
clinical study to assess the efficacy of SMN in Generalized anxiety disorder and
related insomnia.

Name of Company/Sponsor: BIPHA Drug Laboratories

Study Number: C2008/001/BDL/NGR

Protocol Number: 200801SMN

Clinical trial site/unit: Sri Sarada ayurvedic hospital, Nagercoil

Principal investigator: Dr. L. Mahadevan. BAMS, M.D (AY)

Co investigators: Dr. Benezir, Dr. Prathiban

Study Period: 1 December 2008 to 6 January 2009

Phase of Study: Phase II

Primary Objective: The primary objective of the study was to assess the efficacy
and tolerability of SOMNA in treatment of primary insomnia and generalized
anxiety.

Number of patients: A total of 21 patients were planned and taken for the study.
One patient was terminated after a period of 14 days due to the improper
reporting. Eventually a total of 20 patients completed the study and
corresponding case reports forms were taken into account.

Diagnosis and main criteria of inclusion: A set of inclusion criteria and

exclusion criteria were made at the design of the study. Patient recruitment was
made meeting both the parameters.
The patient’s health, informed consent and insomnia suffering were considered
as the main inclusion criteria. Epileptic and psychotic disorders with thyroid
dysfunctions and drug, alcohol toxicities were included in the exclusion criteria.

Study drug dose and mode of administration and administration rate:

SOMNA was administered orally two tablets per day at the bed time for the
study. The dosage rate was not altered at any time of the study. But it was
proposed that the dosage should be immediately stopped at the report of any
adverse events.

Duration of treatment: The study was conducted for a period of 30 days

General Design and Methodology: A single centre, single blind, fixed dosage
randomized study of treatment with SOMNA was proposed for a time period of
30 days in adult patients with primary insomnia and generalized anxiety disorder.
The design consisted of a screening visit followed by three weekly visits during
the study. The patient was permitted to contact the investigator at any time for
the report of adverse events.

Primary Variable and Endpoint: Efficacy was assessed by evaluating the

insomnia and anxiety by the Hamilton Anxiety Measurement Scale (HAMA).
Patients were made to assess by the HAMA at each visit including the screening
visit. Safety/ tolerance were assessed by evaluating adverse events (including
death, serious adverse events and withdrawals due to adverse events), clinical
laboratory tests (serum chemistry, hematology and urinalysis) results, vital signs
(blood pressure, pulse, respiratory rate and temperature) and physical
examination findings.

Statistical Consideration: All patients who completed and reported for the
complete duration of time were evaluated. Data were summarized using
descriptive statistics.

Study Population Demographics: A total of 20 adult patients of mean age of

34.9 years (range from 22 to 46 years) enrolled in the single blind randomized
study. Of the 20 enrolled patients, 13 (65%) were women and 7 (35%) were men.
The percentage shown adverse events were nil.

Efficacy results: Regarding the HAMA scale procedure adopted in the single
blind randomized study on 20 patients; SOMNA proved to have good effects in
the treatment of insomnia and generalized anxiety disorders. The medicine
started to show its effect from the second week of administration for 14 patients
(70%). For remaining 6 patients (30%) it has been of good effect form the third
week.

Safety Results: The duration of the treatment was 30 days and daily dosage
was 2 tablets. No deaths or any adverse events due to the administration of the
drug were observed. The toxicity/tolerable effects of the drug were investigated
by the clinical lab tests as well as the physical observation of the patient. No
significant change in the serum chemistry and urinalysis reports were observed.
Vital sign investigations and physical examination was also found to be positive.

STUDY RESULT: The single centre, single blind, fixed dosage, randomized,
phase II clinical study of found SOMNA to be very effective for insomnia and
generalized anxiety.