Volume 2, No.5, July to September' 2013 - amam-ayurveda.org

Double Blind Randomized Placebo Controlled Clinical Study on
Ashwagandha in Chronic Fatigue Syndrome
INVESTIGATORS
Dr. G. G. Mansharamani, Dr. B. M. Makkar,
Dr. Rachel Koreth, Dr. Gautam Dutta and
Dr. A. Mukherjee
REPORT YEAR: September 1996
1. INTRODUCTION
Chronic Fatigue Syndrome (CFS) is a chronic disorder of unknown
etiology, characterized by persistent lack of drive and energy to carry out
day to day activities and concentrate on work. The fatigue may worsen
with physical or mental activity, but doesn’t improve with rest. There
is no specific laboratory test and clear criteria to identify homogeneous
(sub) groups in patients presenting with unexplained fatigue, and to assess
clinical status and disability in patients of Chronic Fatigue Syndrome.
Number of remedies have been tried out with variable results; Work-up
and therapy have to be based on this integrated approach.
Ashwagandha (Withania somnifera) known for its beneficial effects in
humans may help for combating stress in the patients with Chronic Fatigue
Syndrome. Therefore, the study on Stresscom Capsule (Ashwagandha
Capsule) was conducted to evaluate the efficacy and safety in patients
suffering from Chronic Fatigue Syndrome.
parameters of this study. It was studied by two methods. In the first method,
the patient’s fatigue level was measured on a scale of 0-3, where 0 being
no fatigue and 3 being the maximum fatigue. On the second method, the
number patients achieving a reduction in various level score at the end of
the study was counted and were compared.
Routine investigations e.g. Urine analysis, Chest X-ray PA, Serum
Electrolytes and Alkaline Phosphatase, and other blood parameters were
done before and after the trial.
Decoding was done at the end of the study, Batch B as ‘Stresscom’, and
Batch A was ‘Placebo’.
3. OBSERVATIONS AND RESULTS
A total of 86 patients completed the study, with 39 in Placebo and 47
in Stresscom group. There were 18 males and 21 females in Placebo
group. Stresscom group had 26 males and 21 females. The drugs were
administered at a dose of 2 capsules at breakfast and dinner given for 8
to 12 weeks.
All patients were followed up at 4 week intervals for 8 to 12 weeks, along
with medical check-up and investigations. A careful watch was kept for
side effects, if any.
2. MATERIALS AND METHODS
Patients of Chronic Fatigue Syndrome reporting to the Medical OPD of
LNJP Hospital, New Delhi were selected for the study after a thorough
physical examination. The patients were explained the purpose of the
study and their written informed consent was obtained.
Patients enrolled in the study were randomly divided into two batches A
and B, matched for age, sex, and disease profile. Stresscom and Placebo
were supplied as identical looking capsules coded A or B. The identity of
the code was sealed till the end of the study.
3.1. PHYSICAL EXAMINATION
There was no significant difference found in general physical examination
between both the groups.
3.2. KARNOFSKY PERFORMANCE INDEX (KPI)
Both Stresscom and Placebo groups have shown improvement in the scores
of Karnofsky Performance Scale Index (KPI) in each visit compared to
the baseline, however, no significant difference was found on between the
group analysis (Fig 1).
Figure 1: Karnofsky Performance Scale Index in different visits
Patients with malignancy, autoimmune diseases, tuberculosis, lyme
disease, infectious diseases, AIDS/HIV infection, psychiatric chronic
diseases diagnosed or suggested by history, inflammatory chronic diseases
or chronic hepatitis, neuromuscular diseases like multiple sclerosis
or myasthenia gravis, endocrine diseases like DM, thyroid hypo- or
hyperactivity, adrenal hypo- or hyperactivity, drug dependency, cardiac
disease, GI, hepatic, renal or hematological disease etc were excluded
from the study.
Score
90
85
80
75
70
Basal
4th Week
8th Week
12th Week
The physical examination like heart rate, blood pressure, respiratory rates,
body temperature and body weight was done before and after the study.
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Placebo
Stresscom
The patient’s performance was evaluated on Karnofsky Performance Scale
Index. This Scale helps in classification of patients as per their functional
impairment. The index can be used to compare effectiveness of different
therapies and to assess the prognosis in individual patients. The lower the
Karnofsky score, the worse the survival for most serious illnesses.
The control over the level of fatigue was one of the most important
info Ayurveda, Volume 2, No.5, July - Sept’ 2013
3.3. FATIGUE LEVEL
3.3.1 Control over the level of fatigue – The mean initial fatigue level
was 2.4 ±0.6 and 2.5±0.5 in Placebo and Stresscom group respectively,
which was reduced to 2.1±0.6 and 1.7±0.6 after the study respectively
(Fig 2). The difference was significant.
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