WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES

Mohite et al.

World Journal of Pharmacy and Pharmaceutical

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Volume 3, Issue 6, 1526-1532.

Research Article

ISSN 2278 4357

EVALUATION OF EFFICACY OF DASHMOOLARISHTA IN

CERVIVITIS: A PROOF-OF-CONCEPT STUDY
Swati Mohite*, Esha Kapoor, Bhagyashri Nagarkar1
Bharati Ayurved Hospital, Bharati Vidyapeeth Deemed University, Pune Satara Road, Pune411 043, Maharashtra, India
1

Interactive Research School for Health Affairs (IRSHA), Bharati Vidyapeeth Deemed
University, Pune Satara Road, Pune- 411 043, Maharashtra, India

Article Received on
16 April 2014,
Revised on 07 May,
2014,
Accepted on 22 May 2014

ABSTRACT
Dashamoolarishta, a well known polyherbal formulation used for
different ailments especially for inflammation and need clnical
validation of its efficacy in cervicitis wich is important but neglected
disorder. Present research work was carried out with the aim to

*Correspondence for Author

evaluate the efficacy of Dashamoolarishta on cervicitis. Study was

Dr. Swati Mohite

Bharati Ayurved Hospital,

conducted in perimenopausal patients to assess the efficacy of trial

Bharati Vidyapeeth Deemed

drug Dashamoolarishta. Total of 30 perimenopausal patients were

University, Pune Satara Road,

selected for the study after screening 113 patients. Out of them, 30

Pune, Maharashtra, India.

patients completed the study. The trial drug Dashamoolarishta was

given in the dose of 20 ml BD for 90 days with water and follow up was conducted after
every 15 days. The study revealed the statistically significant decrease in cervical redness,
swelling, low backache. Significant inflammatory changes were observed in pap smear test.
ESR was significantly decreased after treatment. Dashamoolarishta is a potential drug for
cervicitis.
Key words: Dashamoolarishta, efficacy, Cervicitis.
INTRODUCTION
Cervicitis is an inflammation of the uterine cervix, most often caused by infection. However,
in a few cases it may be attributed to chemical exposure or a foreign body, such as a pessary
(a device inserted into the vagina to support the uterus), cervical cap (a birth control device),
or diaphragm. The condition may also be caused by an allergy to contraceptive spermicides

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or to latex in condoms.[1] In cases of cervicitis attributed to foreign objects, infection is still

frequently the cause, but the presence of the foreign object may make the cervix more
susceptible to infection.[2]
There is increasing evidence that Mycoplasma genitalium and Chlamydia trachomatis causes
mucopurulent cervicitis and endometritis in women.[3,4] Sexual partners of M. genitalium and
C. trachomatis infected patients harbour the pathogens of genital tract which are ultimately
responsible for cervicitis as well as urethritis.[5] There are evidences that other causes of
cervicitis may include infections with herpes virus (genital herpes), Ureaplasma urealyticum,
Candida spp., Staphylococcus epidermidis, Lactobacillus and Staphylococcus aureus.[3,6,7]
Along with this some other determinants of cervicitis may include persistent abnormalities of
the vaginal flora, idiopathic inflammation, altered local host immune response etc.
The symptoms of cervicitis include abnormal vaginal discharge, cervical bleeding, cervical
ectopy, elevated vaginal PMNL (polymorpho-nuclear leukocytes) count and vaginal pain.
Also there are evidences that many times it is asymptomatic.[3] Generally antibiotic or
antifungal therapies either orally or per vagina are prescribed to treat this condition. Many
times exogenous hormonal therapies are suggested so as to increase the local immune
response against pathogens.[6] For local tissue destruction in case of chronic cervicitis with
ectropion available treatment options are cryotherapy, electrocauterization, laser therapy, cold
conization or loop diathermy. [8] Although these medicines are well tolerated by majority of
the patients and there are no major adverse effects, the search is always going on to explore
more effective medicine.
Ayurveda considers that all gynecolocical disorders are caused by vitiation of vata dosha.
While treating vata dosha, the drug of choice is Dashamoola. Dashamoola contains
Brihatpanchamoola and Laghupanchamoola. All plants of Brihatpanchamoola have tikta,
kashaya rasa, ushna veerya and katu vipaka, whereas the constituent plants of
Laghupanchamoola have kashaya, tikta rasa, ushna veerya and madhura vipaka.
Dashmoola is mentioned under Shothahara (anti-inflammatory) (Ch./su./4/16, 38) and Vata
hara drugs (Ch./su./3/19). The type of formulation (Arishta) is known to reach small channels
and act with immediate effects. Further, these plants are reported to have anti-inflammatory,
anti-fungal and wound healing properties.[9,10] Individually root extracts of various plants of
Dashamoola viz. A. marmelos,[11] P. integrifolia,[12] D. gangeticum,[13-16] O. indicum[17,18] and

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U. picta,[19] S. suaveolen[20] have exhibited anti-inflammatory potential in vivo. Also in a

comparative study of roots of Dashamoola plants it has shown that all plants as well as
Dashamoola as a whole possess wide-ranging in vivo anti-inflammatory potential.[21a&b]
Dashamoola is also known for having antimicrobial activity.[9]
Dashamoolarishta, a well known drug prepared from Dashamoola is traditionally used as an
analgesic as well as anti-arthritic agent. It is used for cough, rheumatism etc. and also
suggested for ovulation related disorders.[22,23] Dashamoolarishta have shown to posses antiinflammatory activity in cotton pellet induced granuloma and carrageenan induced rat paw
edema models.[24] Also it is shown that Dashamoolarishta has peripheral as well as central
analgesic activity in various animal models.[24,25] In a study it is shown that
Dashamoolarishta possess highest anti-inflammatory potential amongst selected dosage
forms of Dashamoola in carrageenan induced rat paw edema model.[21a]
In our previous work we have studied different market samples of Dashamoolarishta for their
free radical scavenging as well as anti-inflammatory acivity and it was found that
Dashamoolarishta samples have exhibited significant anti-oxidant and anti-inflammatory
activity. [26] Several studies have carried out to validate the potential of Dashamoola churna
and individual plants of Dashamoola but no study has been carried out to evaluate the
efficacy of Dashamoolarishta. With this background, the present study was undertaken to
evaluate efficacy of Dashmoolarishta in patients suffering from cervicitis.
Aim and Objective
To evaluate the efficacy of Dashamoolarishta in cervicitis as an anti-inflammatory agent.
Type of study
Open clinical trial
MATERIALS AND METHODS
Preparation of formulation
Dashamoolarishta was prepared as per the standard procedures mentioned in Ayurvedic
Formulary of India (AFI).[27]
Selection of cases
Total 48 perimenopausal patients (age group 40-60 years) were selected from 113 patients for
the present study after screening 113 patients at Bharati Ayurved Hospital. Out of them 30
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patients completed the study. The study procedures were initiated after obtaining Written
Informed Consent from of each patient.
Dose and duration
The trial drug Dashamoolarishta was given in the standard dose of 20 ml BD for the period
of 90 days with water and follow up was conducted after every 15 days.
Inclusion criteria
Female patient of age group 40-60 years i.e. perimenopausal.
Indoor, outdoor patient suffering from cervicitis.
Exclusion criteria
Age group of menarche.
Pregnant ladies
Cervical polyp patients
Patients with any malignant growth of genitalia
Any other chronic disability related with cervix
Adverse effect evaluation criteria
Possible adverse effects of test drug Dashamoolarishta were recorded during every
followup from patients in the form of information like change in appetite, sleep, drowsiness,
nausea, vomiting, pain in abdomen, stool & urine related complaints (Mala and Mutra) and
other non specific symptoms.
Assessment criteria
Selected patients were assessed using general assessment criteria before and after the
treatment. At the baseline, a detail history with emphasis on the gyanecological and obstetric
details was taken from all patients. Physical and systemic examination was carried out. All
the patients were evaluated for signs and symptoms using subjective as well as objective
parameters.
Subjective parameters
Cervix: Redness, Swelling, Vaginal discharge, Presence of tenderness, hardness & pain
was assessed using gradation method as shown in Table 1
General symptoms: Low backache and Menstrual disorders

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Table 1: Gradation of parameters

Grade
0

Swelling
Normal tissues

Redness
White/
Normal
colour
Pink

Red

Inflammation

Deep red

Erosion and
inflammation

Granulation
tissue complete

Discharge
No complaint
of white
discharge
Vaginal and
vulvar
moistness
Severe quantity
: needs pad

Tenderness
No pain

Pain
No pain

Tenderness on
touching
cervix
Tenderness on
mobilization
of cervix

Pain while
work
Pain felt while
work and rest
and needs
painkiller

Tenderness of the Cervix: graded as Normal, Soft like lips and Hard, Swelling when there is
feeling different from lips
Objective parameters
Blood parameters (VDRL, HIV, Haemogram Hb%, TLC, DLC, ESR)
Urine Routine and Microscope
Other parameters
Age, Weight, Prakruti, Parity, Abortions, Mode of Delivery, Mutra, Mala and Yoni-vyapada
The patients were screened for VDRL and HIV tests to rule out the concerned diseases. They
were also investigated for Pap smear tests, blood parameters like Hb%, TLC, DLC, ESR and
urine routine and microscopy examination.
Follow-up and monitoring
All registered patients were called for follow up after every 15 days for the period of 90 days.
During followup, patients were observed for signs and symptoms of cervicitis.
Ethical clearance
The present work was reviewed and discussed by Institutional Ethics Committee and has
been approved on 09 April 2012 (Letter no-F10 (5)/EC/2012/292).
Assessment of results and progress
The data of the clinical study was analyzed after the treatment for the effect on cervical
redness, swelling, vaginal discharge, presence of tenderness, hardness & pain.

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Statistical Analysis
The data are expressed as Median (Range). Pre and Post treatment values were analyzed
using Wilcoxan Rank Sum Test. p<0.05 was considered as level for significance. All analysis
was done using Graphpad Instat Version 3.
OBSERVATION AND RESULTS
Over a period of 08 months, 113 names of patients with low back pain as their main
complaint were referred to the study. Out of these, 48 patients were included in the study.
Total 18 patiens were drop out from the study due to their discontinuation of treatment. The
remaining 30 patients were investigated for the study.
The mean age of recruited patients was 52.23 4.79 years. Prakriti evaluation of these
patients showed almost equi-distribution of all 3 prakriti types (9 patients each of Kapha and
Vata prakriti and 12 patients of Pitta prakriti). Out the 30 patients, 1 patient was
nulliparaous, 4 were primi para and 25 were multi-para. 26 patients gave history of normal
delivery and 4 patients had LACS. In 23 patients, there was no history of abortion where as
single abortion reported in 6 patients and multiple abortions in 1 patient. 21 patients gave
history of abdominal surgery, while 16 patients gave history of Urinary Tract Infection. There
was history of ano-rectal conditions like piles and fissures in 10 patients.
Effect of Dashmoolarishta on signs and symptoms of cervicitis:
The signs and symptoms of cervicitis were evaluated pre and post treatment using the scores
as described in materials and methodology. The results are summarized in Table 2.
Table 2: Effect of Dashmoolarishta on signs and symptoms of cervicitis
Signs/symptoms
Cervical Tenderness
Redness of Cervix
Swelling of cervix
Low backache

Pre-treatment
1 (0-2)
1 (0-2)
1 (0-2)
1 (0-2)

Posttreatment
0.5 (0-2)***
0 (0-2)***
0 (0-1) ***
0 (0-1) ***

Data expressed as Median (Range), (***p<0.001) using Wilcoxan Rank Sum Test as
compared to Pre-treatment values

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All the parameters showed significant decrease after administration of Dashmoolarishta.

Cervical tenderness that was graded as normal and hard did not show any change post
treatment.
Effect of Dashmoolarishta on Pap smear
29 patients showed inflammatory changes in Pap smear pre-treatment, which was changed to
mild inflammatory changes in 4 patients and no inflammatory changes in 15 patients. In 10
patients no change was seen. These changes were statistically significant when analysed
using Chi square test (p<0.001).
Effect of Dashmoolarishta on blood parameters:
Total leucocyte count and ESR was estimated in all patients in both pre and post treatment
and wich ESR showed significant decrease after administration of Dashmoolarishta.
Table 3: Effect of Dashmoolarishta on blood parameters
Parameter
TLC (/cu.mm)
ESR (mm/hr)

Pre-treatment
8900 (4800- 14100)
19 (7-40)

Post- treatment
8300 (5200-14200)
16 (5-30)***

Data expressed as Median (Range), (***p<0.001) using Wilcoxan Rank Sum Test as
compared to Pre-treatment values
DISCUSSION
In the present study, we evaluated the efficacy of Dashmoolarishta in cervicitis.
Dashmoolarishta is recommended to treat inflammation of joints. It is also used in various
gynecological conditions and even in post-partum peruid. There are anecdotal reports
available on its use in cervicitis.[22,23] However, no clinical studies have been found in
literature evaluating its efficacy in cervcitis.
An open, non-comparitive study was carried out in 30 patients. We observed higher
prevalence of cervicitis in multi-para females, those with history of normal delivery and in
the patients who had Urinary Tract Infection in the past indicating assocaiation of these
factors with the development of cervicitis. Interestingly, there were 10 patients with history
of ano-rectal conditions like piles and fissures highlighting role of pre-existing Apan vayu
dushti mentioned in Ayurveda as an important causative factor.

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Dashmoolarishta when given in a dose of 20 ml BD for a period of 90 days showed

significant improvement in all the signs and symptoms. It also significantly improved
inflammatory changes observed in vaginal smear. The total leukocyte count showed
reduction as compared to baseline and ESR reduced significantly indicating resolution of the
underlined infection.
In support of these results, some of the Dashamoola plants have been examined for their antiinflammatory potential viz. A. marmelos,[11,28] P. integrifolia,[12] D. gangeticum,[13-15,16] O.
indicum,[17,18] U. picta,[19] S. suaveolens.[20] Also there are reports on antimicrobial activity of
some of the Dashamoola plants viz. Tribulus terrestris,[29,30] Premna serratifolia,[31] Solanum
xanthocarpum.[32] Along with these Dashamoola as a whole also exhibited anti-microbial
activity against some bacteria and fungi.[9] These reports advice that the obtained activity of
Dashamoolarishta in present study is might be due to anti-inflammatory as well as antimicrobial activity of ingredient plants of Dashamoola.
Similar studies are reported on different herbal formulations. In an open clinical trial, women
suffering from vaginitis and cervicitis were suggested for topical application of V-Gel (a
polyherbal formulation) on the vagina and cervix. Reduced soreness of cervix, pruritus,
inflammation of vulva, vaginal discharge within two weeks of drug treatment suggested that
V-Gel was clinically effective formulation for the treatment of vaginitis and cervicitis.[33].
Another clinical study conducted on a famous Unani formulation, Marham Dakhlion has
shown that it is effective on chronic cervicitis and cervical erosion. Study has shown that the
formulation was effective in 80% of the cases.[34]
These studies are in concored with the present investigation and revealed that
Dashamoolarishta is exhibiting anti-inflammatory activity against cervicitis. This study
however has some limitations. Since it was an open study with no comparator especially in
view of the subjective nature of parameters, it did not completely rule out bias on the part of
the investigator and placebo response on the part of the patients. Inclusion of microbiological
outcomes assessing the clinical isolates from Pap smear could be used for future studies of
this kind in addition to inflammatory markers specific to cervicitis. Our findings further open
up new avenue to test the formulation for cervicitis with respect to cytological as well as
molecular changes.

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CONCLUSIONS
Thus, our study reports the efficacy of Dashmoolarishta in cervicitis for first time without
any adverse effect.
ACKNOWLEDGEMENT
Authos acknowledge all those patients participated in the study. Authors also acknowledge
help of Ms. Naina Pawar, Ms. Supriya Bhalerao and Dr. Suresh Jagtap for helping in
developing concept, laboratory work, statistical analysis, writing and reviewing the
manuscript.
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