Issue : 01 DOI :
INTERNATIONAL
JOURNAL
OF
DIAGNOSTICS
AND
RESEARCH
Volume : 02
Copyright @ : - Dr.Bhagya Ranjan Dash Inter. J.Digno. and Research IJDRMSID00026 |ISSN :2584-2757
26
Abstract
Introduction (Background) - The health of society depends largely on the health ofwomen. A woman should
have normal regular menstrual cycle in order to maintain normal reproductive health. Now a day, Polycystic
Ovarian Syndrome is becoming a major health problem worldwide. It is a major non-communicable health
problem affecting the women of different age groups.
Methods - 33 clinically diagnosed patients of Nashtartava were selected from OPD and IPD of Prasuti Tantra
and Stri Roga department of NIA, Jaipur as per criteria of inclusion. These patients were randomly divided into
two groups and the study was completed on 30 patients;15 patients in each group.
Result - It was found on comparing both the groups on the basis of symptomatic improvement, that, average
percentage of relief was higher in ‘Group A’ i.e., 67.41%, while that in case of ‘Group B’ was found 55.92%.
Thus, the effect of therapy was found more in ‘Group A’ in comparison to ‘Group B’.
Conclusion - Shatapushpa Churna was found more effective than Madhutailika Basti in improving the
symptoms of Nashtartava (w. s. r. to PCOS).
Keywords : Madhutailika Basti, Nashtartava, Oligomenorrhoea, PCOS, Shatapushpa Churna.
Corresponding author: Dr. Bhagya Ranjan Dash
Article Info: Published on : 15/10/2024
P
Publisher
ROGANIDAN VIKRUTIVIGYAN PG ASSOCIATION
FOR PATHOLOGY AND RADIODIGNOSIS
DOI
: 1 0 . 5 2 8 1 / z e n o d o . 1 3 9 3 6 4 6 3
Reg. No. : MAHA-703/16(NAG)
Year of Establishment – 2016
INTERNATIONAL JOURNAL OF DIAGNOSTICS AND RESEARCH
A Randomized Control Open Label Clinical Trial on the Efficacy of
Shatapushpa Churna and Madhutailika Basti in Nashtartava w. s. r. to
Polycystic Ovarian Syndrome
Dr. Shalvi Sharma
1
, Dr. Bhagya Ranjan Dash
2
1
Ayurvedic Medical Officer, GAHC Kharsi, Distt. Mandi, H.P. (Previous M.S. Scholar,
Prasuti Tantra evam Stree Roga, NIA, Jaipur.)
2
Assistant Professor, PG Dept. of Roganidan, Govt. Ayurvedic College & Hospital, Tulasinagar, Balangir,
Odisha.
Cite this article as: - Dr. Bhagya Ranjan Dash (2024) : A Randomized Control Open Label Clinical Trial on the Efficacy of
Shatapushpa Churna and Madhutailika Basti in Nashtartava w. s. r. to Polycystic Ovarian Syndrome;
Inter.J.Dignostics and Research 2 (1) 26-34, DOI: 1 0 . 5 2 8 1 / z e n o d o . 1 3 9 3 6 463
G
A
R
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27
Introduction :
PCOS is becoming a burning health issue as it may
lead to several serious complications like diabetes
mellitus, cardiovascular diseases, hypertension,
endometrial carcinoma, breast cancer etc. in later life.
Due to adoption of western culture by most of the
women and increased stress and strain in day-to-day
life, the incidence of Polycystic Ovarian Syndrome is
increasing alarmingly in adolescent and women of
reproductive age group along with other life style
related disorders. In India, out of every 5 women
[1]
is
affected with PCOS, having prevalence in 20 – 30
years age group. It is diagnosed on the basis of
presence of any two out of the following three criteria,
viz., Oligo and or anovulation, Hyperandrogenism
(Clinical and /or biochemical), polycystic ovaries
[ASRM/ESHRE, 2003]. Women who are having
irregular menstrual periods have very high chances of
having PCOS (91%) and the women who are suffering
from PCOS are 15 times more likely to suffer from
infertility.
[2]
As per Ayurveda, any change in the equilibrium of
Doshas, Dhatus and Malas, leads to Samprapti of the
diseases. As PCOS is a syndromic condition, so it
cannot be correlated with a single disease condition,
but given under the headings Yonivyapad (genital
disorders) and Artava Dushti(menstrual disorders) as
per Ayurvedic literature is concerned. After describing
eight disorders of Artava, Nashtartava has been
described by Acharya Sushruta andVagbhata
respectively
[3,4]
. , Nashtartava is a symptom as well
as a disease caused due to vitiation of Vata and Kapha
Doshas as they cause Margavarodha of Artava Vaha
Srotas leading to absence of menses or abnormal flow
of Artava. Acharya Vagbhata mentioned that, due to
Vata and Pitta, the Raja is decreased leading to
Lohitakshaya.
[5]
Decreased menstrual flow is the main
feature of Vataja Yonivyapad, Rajodhatu Kshaya,
Vataja Artava Dushti, Kshina Artava Dushti etc.
Acharya Kashyapa described Pushpaghni Jataharini
which is having features like Vrutha Pushpa (futile
ovulation) and Sthula Lomasha Ganda (hairy cheek).
[6]
The features of PCOS may also be correlated with
these. Acharya Bhavamishra also mentioned about
Nashtartava in Yoniroga Chikitsa Prakarana.
[7]
Initially, in early stage, PCOS could be considered as
aVata-Kapha predominant disease and later on in
chronic condition, it becomes a Tridoshaja Vyadhi due
to involvement of all three Doshas. Here, mainly Rasa
Dhatudushti is involved, due to which improper
Artava Upadhatu formation occurs.
Materials and Methods Patients:
33 clinically diagnosed patients of Nashtartava
were selected from OPD and IPD of Prasuti Tantra
and Stri Roga department of NIA Jaipur as per
criteria of inclusion.
Inclusion criteria :
Female patients of age group between 18 – 40
years (Both married and unmarried).
ASRM/ESHRE (Rotterdam) Criteria, 2003-
Affected individuals must have two out of
three criteria :
1. Oligo and /or anovulation
2. Hyperandrogenism (clinical and /or
biochemical).
3. Polycystic ovaries (Confirmed on USG).
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Exclusion criteria :
Women of age <18years and >40years.
Patients with chronic systemic illness
(Congestive cardiac failure, Hypertension,
cirrhosis of liver, chronic renal disease,
diabetes mellitus, Tuberculosis etc.).
Patients using oral contraceptive pills.
Patients with any organic reproductive
system abnormalities (Excluded clinically
and radiologically), pelvic inflammatory
disease, hydrosalpinx, endometriosis,
adenomyosis, fibroid uterus, carcinoma of
reproductive organ.
Any type of malignancy.
Patients with positive Sexually transmitted
diseases (STDs), Human Immunodeficiency
Virus HIV, Hepatitis B Surface Antigen
(HbsAg).
Patients suffering from adrenal hyperplasia,
severe insulin resistance, androgen secreting
neoplasm, thyroid abnormalities, Cushing’s
syndrome.
Drugs :
Drugs for both the groups were procured
from the pharmacy of NIA Jaipur.
Shatapushpa Churna in the form of coarse
powder and Basti drugs were obtained
separately in the form of raw drugs. Report
of drug analysis was obtained from the Drug
Testing Laboratory of NIA Jaipur.
Investigations :
Blood and serological tests - Complete Blood
Count, Erythrocyte Sedimentation Rate, VDRL
(Venereal Disease Research Laboratory), HIV
(Human Immunodeficiency Virus), HBs Ag
(Hepatitis B Surface Antigen), Random Blood
Sugar, RFT (Renal function test), LFT (Liver
function test). Urine routine and microscopic
investigations were done. Hormonal tests
including FSH (Follicle Stimulating Hormone),
LH (Luteinizing Hormone), PRL (Prolactin),
Thyroid function test (TFT). USG were done on
2
nd
or 3
rd
day of menses.Investigations like
Hemoglobin, Total Leukocyte Count, Erythrocyte
Sedimentation Rate, Random Blood Sugar, Liver
Function Test, Renal Function Test, Thyroid
Profile, Serum Luteinizing Hormone and Serum
Follicular Stimulating Hormone.
Study Design: A randomized control open label
clinical study was done. Before taking the patient
in trial, informed consent was taken from every
patient.
Management of patients :
Drug dosage, duration, and method of
administration
Grouping :
From the selected patients, two groups were made
by randomly dividing them.
Group A : Shatapushpa Churna was given orally
to the patients before meals in a dose of 6gm,
twice a day with Goghrita and warm water.
Medicine was started from 1st day of menses and
was continued for 3 consecutive cycles. Total 17
patients were clinically diagnosed and registered
in Group A, out of which 15 continued the
treatment and 2 patients discontinued.
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Group B – Madhutailika Basti was given in a
dose of 400ml through anal route empty stomach
in morning. In case of irregular cycles, it was
given for 7 days (after initial screening), then
there is a waiting period of fifteen days, during
which the patient may get her periods. The next
seven days of medicine is started seven days prior
to the expected date of next menstruation, in case
she does not get her periods, medicine again
started for seven days, after the waiting period,
this follows for three cycles of medicine
administration. While, in case of regular cycles,
Basti was given seven days prior to the expected
date of menstruation for three consecutive cycles.
Total 16 patients were clinically diagnosed and
registered in Group A, out of which 15 continued
the treatment and 1 patient discontinued.
Duration – 90 Days / 3 Menstrual Cycles.
Pathya – Apathya :
Pathya Ahara – Patients were advised to take
Yava, Shali Rice, Tila, Tila Taila, Matsya,
Kulattha, Amla Dravyas, Masha, Dadhi
i
,
Puranaghrita, Purana Raktashali, Mudga,Patola,
Raktashigru, Ruksha, Katu, Deepana Dravyas,
Guggulu, Shilajatu.
[9]
Pathya Vihara – Patients were advised to
develop the habit of reading good books, doing
regularYogaandPranayama(Kapalabhati,Anulom
a–Viloma,Bhramari,Suryanamaskara,
Paschimottana Asana, Halasana, Sarvangasana,
Shalabhasana, Makarasana etc.), brisk walking,
Bramha-Muhurta Jagarana, taking dinner before
sunset, Chankramana, early sleeping habits,
meditation, Sharirika and Manasika
Bramhacharya, Kala Maithuna, Achara
Rasayana.
Apathya Ahara – Patients were asked to avoid
Kaphakara, Vatadushtikara,
MedovriddhikaraAhara;Atyashana,Adhyashana,
Vishamashana,ParyushitaAhara, Atisheeta
Udaka Evam Ahara, Ruksha Ahara e.g., Besana
etc, Vatala Ahara e.g., Potato, Chickpea, ladies’
finger etc., Navanna, Kodrava, Nishpava, Kalaya,
Gramya Mamsa, Anupa Mamsa, Varaha Mamsa,
Gomamsa, Shushka Shakha, Sheetala Jala,
Mahisha Khseera, Phanita, artificial sweeteners,
Ruksha, Guru Anna, Abhishyandi Dravya, Fast
food, spicy foods, Panipuri, burger, pizza,
chocolates, cold drinks, fermented foods, oily and
fried food.
Apathya Vihara – Patient was asked to avoid
Divaswapna, Ratrijagarana, Avyayama,
Vegadharana, Ativyavaya, Atichinta, Atibhaya,
Atikrodha, Atishoka.
Follow up :
1. During trial –After completion of every
menstrual cycle.
2. After completion of the trial, the cases were
followed up to one consecutive menstrual cycle.
Assessment Criteria :
Before and after the treatment, clinical features
were observed and assessed and at the end, total
effect of therapy was evaluated in every patient.
To assess the clinical improvement, a specific
scoring pattern was framed.
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Assessment of overall response :
Statistical analysis :
The data was subjected to statistical analysis after
obtaining observations. P < 0.05 was considered
as statistically significant. P < 0.01 or P < 0.001
was considered as statistically highly significant.
P > 0.05 was considered as statistically non-
significant.
Observation and Result :
In the present study out of total 30 patients,
majority i.e. 22 (73.33%) were from 18 – 25
years age group, 23 (76.67%) patients were
Hindus,25 (83.33%) were unmarried, 26
(86.67%) patients were from urban habitation, 03
(10%) patients took allopathic medicine for the
same problem previously, 20 (66.67%) revealed a
positive family history, oligomenorrhoea was
present as a chief complaint in maximum 26
(86.67%) patients, reduced quantity of flow was
present in 18 (60%) patients, hirsutism was
present in 19 (63.33%) patients, mid-body obesity
was present in 17 (56.67%) patients, acne was
present in 17 (56.67%) patients, acanthosis
nigricans was present in 04 (13.33%) patients,
alopecia was present in 15 (50%) patients,
infertility was present in 04 (80%) married
patients, menstruation was irregular in 19
(63.33%) patients, 11 (36.67%) patients were
having chronicity more than 3 years, interval of
bleeding was found > 45 days in 50% patients,
maximum 16 (53.33%) patients were having
scanty menstruation, mild pain during menses
in15(50%) patients,18(60%) were
vegetarian,13(43.33%) patients were doing
Vishamashana, maximum 21 (70%) patients were
having addiction of tea, 08 (26.67%) patients
were having waist-hip ratio > 0.86, 12 (60%)
patients were having Ferriman and Gallwey score
≥8, maximum patients showed predominance of
Pitta Kaphaja Prakriti (40%), maximum 40%
patients showed predominance of Satva Tama
Dosha,40% patients were having12 follicles in
right ovary and 30% patients were having12
follicles in left ovary, 53.33% patients were
having right ovarian volume10cc and 56.67%
patients were having left ovarian volume10cc, in
76.67% patients endometrial thickness was
between 5 – 12mm, in10% patients LH level was
>15mIU/ml, in23.33% patients, FSH level was
>10mIU/ml, in 10% patients, PRL level was >25
ng/ml.
In group A, statistically significant results were
found in Amount of bleeding, Duration of
bleeding, Hirsutism and Waist-Hip Ratio.
Statistically Highly significant results were found
in Interval of period, Pain during menses, Acne,
Reduction in weight and BMI.
In group B, statistically significant results were
found in Duration of bleeding, Amount of
bleeding and Waist-Hip Ratio. Statistically
Extremely significant result was found in Interval
of period, Pain during menses and Acne. On
comparing both the groups, statistically
significant result was found in Amount of
bleeding and Pain during menstruation
Effects
Percentage of Relief
Good
>75-100 %
Fair
>50-75 %
Poor
>25-50 %
No response
≤25%
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[Graph no.-1.]. Changes in hematological
parameters were within normal limits.
Graph no. – 1 : Showing Percentage relief
in subjective parameters in both groups
Average Percentage of relief
After comparison of both the groups, on the basis
of symptomatic improvement, it was found that
average percentage of relief was higher in ‘Group
A’ i.e., 67.41%, while that in case of ‘Group B’
was found 55.92%. Thus, the effect of therapy was
more in ‘Group A’ in comparison to ‘Group B’
[Table no. -1.].
So, based on above results null hypothesis is
rejected and alternate hypothesis is accepted that
Shatapushpa Churna is more effective than
Madhutailika Basti in treating Nashtartava (w. s. r.
to PCOS).
Subjective Parameters
Symptom
Result in Percentage
Group A
(in %)
Group B
(in %)
Interval of period
74.28
82.77
Duration of bleeding
75.00
60.01
Amount of bleeding
82.37
55.01
Pain during
menstruation
72.73
56.65
Hirsutism
19.35
7.99
Acne
80.78
73.11
Average % of Relief
67.41
55.92
Table no. 1: Showing Percentage Improvement of
Subjective and Objective Parameters in Both
Groups (Group A, n=15 and Group B, n=15)
Overall Effect of Therapy :
On comparison of symptomatic improvements, it
was found that overall relief was higher in Group
A, where 6.67% (01) patients showed good
response, 60% (09) patients showed Fair response,
26.67% (04) patients showed Poor response while
6.67% (01) patients showed no response to the
therapy. In group B, none (0%) of the patients
showed good response, 46.67% (07) patients
showed Fair response, 46.67% (07) patients showed
Poor response while 6.67% (01) patients showed no
response to the therapy [Table no. – 2].
S.
No.
Effect
of
Therapy
Percentage
% of Relief
Group A
Group B
No
.
%
No.
%
1.
Good
>75-100 %
01
6.67
00
00
2.
Fair
>50-75 %
09
60
07
46.6
7
3.
Poor
>25-50 %
04
26.6
7
07
46.6
7
4.
No
response
25%
01
6.67
01
6.67
Table no. 2. : Showing Overall effect of therapy in
both groups
Adverse Drug Reactions :
No any complications were found during treatment
and follow up in patients of both the groups (Group
A – Shatapushpa Churna, Group B – Madhutailika
Basti).
Discussion :
Effect on Interval of menstruation: Statistically
extremely significant result was found in both the
groups but comparatively group B shown better
result this was due to Shodhana property of
Madhutailika Basti, which works on Margavaroga
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and causes the Vatanulomana, Thus, normalizing
the interval of menstrual cycle.
Effect on Duration of bleeding :
Statistically significant result was found in both the
groups. This could be due to the Ushna, Tikshna,
Srotoshodhaka properties of Shatapushpa Churna,
which results in Pitta-Vardhana and
Srotoshodhana.
Effect on Amount of bleeding :
Both the groups showed significant results on
normalizing the scanty menstrual flow. But
comparatively group A shown better result, this was
due to the above-mentioned properties of
Shatpushpa Churna, which was found better than
Madhutailika Basti.
Effect on Pain during menstruation :
Statistically extremely significant results were
found in both the groups. Maximum relief was seen
in Group A. This may be due to the Vata Shamaka
property of Shatapushpa Churna.
Effect on Hirsutism :
Statistically significant results were found in group
A and statistically non-significant results were
found in group B. This shows that better effect was
found in group A, where an effective control was
found on further hair growth. The probable reason
for this could be that Shatapushpa Churna doing
the Vata-Shamana, thus causing a decrease in
Malaroopa of Asthi Dhatu.
Effect on Mid-body Obesity (in terms of Waist-
hip Ratio) :
Statistically significant result was found in both the
groups. Reduction of weight was found maximum
in group A, this may be due to the Agni- Vardhaka
property of Shatapushpa Churna, which increases
the Upachaya of Meda and Mamsa Dhatu.
Effect on Hormonal analysis :
Both the groups showed statistically non-significant
results on reduction of serum LH level, Reduction
of Serum FSH level and Serum prolactin level. This
was may be due to short duration of therapy due to
which, no any significant result was found on
hormonal analysis.
Probable Mode of Action of Drugs :
As Guda have Siras and Dhamanis it is considered
as Shareera Moola. These Shiras and Dhamanis,
spread all over body
[10]
. Due to this reason, after
entering into Pakvashaya, Basti works on entire
body. It works by both, local as well as systemic
mode of action. Basti helps in pacifying the vitiated
Apana Vata resulting in proper Vata Anulomana.
This result in enhancement of Purisha function i.e.
‘Anila – Anala Dharana’
[11]
. In this way, it corrects
Agni Dushti, resulting in proper Rasa Dhatu
Nirmana and Artava formation, which leads to
proper Beeja Nirmana and normal Rajah
Pravartana. Shatapushpa is Balya, Deepana,
Pachana, Yonivishodhana, Artavajanana and
Beejotsarga. Shatapushpa is mentioned as
Vataprashamani in Sathapushpa- Shatavari
Kalpadhyaya of Kashyapa Samhita
[12]
. It helps in
alleviating Vata, which is the major factor in
development of all Yoni Rogas. Agneyatva of
Shatapushpa helps in Artavajana and acts as
Ritupravartini (initiates menstruation or ovulation)
and Yoni-Shukra Visodhini. According to the
modern science, absorption of drug occurs through
the mucosal layer when given through the rectal
route. After entering into the gastro-intestinal tract,
Enteric Nervous System (ENS) is stimulated by
Basti and stimulatory signals are generated for
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Central Nervous System (CNS)
[13]
. Endogenous
opioids (mainly β-endorphin), which are present in
GIT, are stimulated by these signals resulting in
inhibition of GnRH release
[14]
. Thus regulating the
H-P-O axis. This results in the normalization of
ovarian and menstrual cycle.
Conclusion :
On comparison of both the groups, on the basis of
symptomatic improvement, it was found that
overall percentage of relief was higher in ‘Group A’
i.e., 67.41%, while that in case of ‘Group B’ was
found 55.92%. This shows that effect of therapy
was a higher in Group A in comparison to group B,
which suggests that probably oral administration of
Shatapushpa Churna increases the Artava quantity
due to its Pitta-Vardhaka Property along with the
removal of Avarana from Artavavaha Srotas. Also,
the method of drug administration, which includes
the Goghrita along with Shatapushpa Churna,
having Yogavahi property, could be responsible for
better results. No any complications were found
during treatment and follow up in patients of both
the groups (Group A – Shatapushpa Churna, Group
B – Madhutailika Basti). Thus, these treatment
options are safe, comparatively economic, non-
surgical and effective. So, these can be used for the
treatment of Nashtartava and PCOS.
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by Hiralal Konar, Chapter 28, 6thedition.
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(Vriddha Jivakiyam Tantram), Kapla
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ISSN: 2584-2757
DOI : 10.5281/zenodo.13936463
Dr. Bhagya Ranjan Dash Inter. J.Digno. and Research
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