A Study on Ayurveda Poly Herbal Compound of Yogaratnakar (17 - A.D.) w.s.r. Rakta-Pradara (Abnormal
Uterine Bleeding)
Research Article
Adwani NV1*, Paramkush
Rao. M2
1. P.G. Scholar final Year, 2. Prof and HOD, P.G. Dept of Dravyaguna, S.V.
Ayurvedic College, Tirupati (A.P.)
*Corresponding
Author: Adwani NV, P.G. Scholar
final Year, P.G. Dept of Dravya Guna,
S.V. Ayurvedic college, Tirupati (A.P.); Email:
dr.nomina.727@gmail.com, Mob: +918801082202
Abstract
Rakta Pradara (Abnormal
uterine bleeding) is commonest
problem encountered by gynecologist in today’s practice and incidence becomes
higher with degree of civilization. Various treatments prescribed in modern
medicine like HRT, Antifibrinolytic agents etc have
not proved their definite efficacy Inspite of high
price and side effect. The present study titled “Clinical study of Shatavari Yashti yoga on Rakta-Pradara w.s.r. to Yogaratnakar” was
aimed to observe the efficacy of the trial drug Shatavari
Yashti Yoga (Poly herbal compound) in Rakta Pradara (Abnormal uterine bleeding). The clinical study was conducted on 30 patients
selected randomly and divided in to three groups based on the drug for the
clinical trial. Group 1- Shatavari
Yashti Yoga with Anupana Tandulodaka; Group 2 - Shatavari
Yashti Yoga without Anupana
and Group 3 – Placebo with Tandulodaka.
The Clinical assessment was done on the basis of grading criteria with
specific Symptomology of Rakta
Pradara (Abnormal
uterine bleeding) like Amount
and duration of bleeding, intermenstrual bleeding,
Pain, burning sensation, pallor, and weakness then mean scores levels of these Symptoms before
and after the treatment of all three groups were subjected for student paired
‘t’ test for statistical analysis. Conclusion: The results were statistically
and clinically significant not only to cure Rakta
Pradara but also in improving general health of
women.
Keyword: Rakta Pradara, Yogaratnakar, Shatavari Yashti Yoga, Tandulodaka.
Introduction
Raktapradara is an excessive or prolonged flow of blood
occurring in menstrual or inter menstrual period as per manuscripts of Ayurveda
it
shows close resemblance with Abnormal uterine bleeding where following pattern
of abnormal and excessive uterine bleeding is found like Menorrhagia - Prolonged or excessive bleeding occurs at
regular intervals; Metrorrhagia
- Irregular, frequent uterine bleeding of varying amounts but not excessive; Meno-Metrorrhagia
- Prolonged or excessive bleeding at irregular intervals; Dysfunctional
uterine bleeding (DUB) - Abnormal uterine bleeding not caused by pelvic
pathology, medications, systemic disease or pregnancy, is the most common cause
of abnormal uterine bleeding but remains a diagnosis of exclusion.(1)
All
the above pathologies can be correlated with Rakta Pradara. So many
preparations have been mentioned in ayurvedic classic
for the treatment of Rakta Pradara. All
these medications have certain fundamental Principles. These are Rakta shodhaka
(blood purifier), Sthambhaka
(Haemostatic), balya
(reduces weakness) etc.
Samprapti vighatana and
effective control and cure in Rakta Pradara are the main with which the drugs were
selected. In pathogenesis of Rakta Pradara Rasa, Rakta, and vata dosha are main responsible factors. Shatavari Yashti Yoga (Poly herbal compound) Plays
an important role to alleviate this pathology, and effectively controls the
bleeding. It also helps to cure the complications which occur due to heavy
uterine bleeding (pallor, burning sensation, weakness). Shatavari Yashti Yoga is pure herbal compound, non hormonal, cost
effective and harmless remedy.
Due to limitation of medical therapy as
well as surgical therapy of modern science, it becomes necessity of the time to
find out an effective harmless therapy with the help of Ayurveda to manage the conditions and keeping this in view the polyherbal compound Shatavari Yashti Yoga with Tandulodaka
(SYT) from Yogaratnakar
(classical lexicon of Ayurveda) from Pradara Chikitsa (chapter
deals with gynecological problems)(2) is selected to conduct the study on
most prevalent disorder in present times called Raktapradara(Abnormal Uterine bleeding).
Aims and
objectives
1. To
provide a simple, safe and non-hormonal herbal drug for the patients of Raktapradara (Abnormal uterine bleeding).
2. Evaluation
of therapeutic efficacy of polyherbal compound Shatavari –Yashti Yoga.
3. To
analyze the influence of vehicle (Anupana) i.e. Tandulodaka (Rice wash water) in the patients of Raktapradara (Abnormal uterine bleeding).
Material and
method
The
Material taken for the study were,
A) Drugs - Shatavari wet root (roots of Asparagus racemosus Willd.)
Yashtimadhu dry root (roots of Glycyrrhiza glabra Linn.)
Sita / Mishri (Sugar candy)
Vehicle (Anupana) - Tandulodaka (Rice wash water)
Preparation of Shatavari Yashti Yoga
Shatavari Swarasa (juice of roots of Asparagus racemosus Willd.) + Yashtimadhu churna (powder of roots of Glycyrrhiza
glabra Linn) + Sita/mishri (Sugar Candy). Mix well all the
contents then this Mixture was dried under hot air oven at 40 ®c for 1 day.
Next day it was grinded in hammer crusher and granulated for the convenience of
drug administration purpose.
Method - Study
Design
For the Present clinical Study total number of
39 patients were registered and screened in to 3 groups for the clinical trial.
The effects of the therapies were screened in 30 patients who have completing
the therapy. The patients were sourced from two different sources-
1) OPD
& IPD of PG Department of Dravya Guna from S.V. Ayurvedic Hospital, Tirupati.
2) By
organizing weekly free camp in S. P.W. Junior Girls Hostel, Tirupati.
Criteria for inclusion of the patients
1. Age
between Menarche and Menopause (12-50 yrs.)
2. Excessive
bleeding during menstruation (change of more than 3 soiled pads/day)
3. Passing
of large clots.
4.
Prolonged Menstrual bleeding (more than
7 days)
5.
Excessive bleeding for more than 2
consecutive cycles
6. Intermenstrual
Bleeding
Criteria for exclusion of the patients
1. Intrauterine
growth such as Myomas, endometrial polyp etc.
2.
Cancer of cervix and or uterus.
3.
Hb less
than 6 gm %.
4. Any
other systemic disorders likely to influence menstrual cycle.
5. Case
undergoing treatment for any other serious illness.
6. Woman
.using an IUCD/ OCP.
7. Venereal
disease.
8. Systemic
cause mentioned below will also be kept under exclusion criteria.
·
Severe hypertension
·
Liver dysfunction
·
Congestive cardiac failure.
·
Patient having bulky uterus
·
Patients having bleeding from sites
other than uterus
·
Patients having coagulation disorder
Investigations
|
Blood |
Hb%, TLC, DLC ,ESR ,CT , BT. |
|
USG |
To rule out uterine pathologies. |
CLINICAL ASSESSMENT
Subjective Assessment
The patients undergone treatment were assessed for
efficacy of Shatavari –Yashti Yoga on basis of grading
criteria depicted below for improvement in specific symptomatology
of Rakta Pradara(Abnormal
uterine bleeding).
1. Bleeding
amount in no. of pads
|
Sr. no. |
Bleeding Amount (No. of pads/
day) |
Grade |
|
1. |
1-2 pads/day |
0 |
|
2. |
3-4 pads/day |
1 |
|
3. |
5-6 pads/day |
2 |
|
4. |
7and above pads/day |
3 |
2. Duration
of flow or menstrual period (In no of days)
|
Sr. no. |
Duration of Bleeding in no
of days |
Grade |
|
1. |
3-5 days |
0 |
|
2. |
6-7 days |
1 |
|
3. |
8-9 days |
2 |
|
4. |
9 and above days |
3 |
3.
Interval of Menstruation (in no. of
days)
|
Sr. no. |
Interval of Menstruation (Gap
between two cycles) |
Grade |
|
1. |
25-30 days |
0 |
|
2. |
20-24 days |
1 |
|
3. |
15-19 days |
2 |
|
4. |
Less than 15days |
3 |
4. Pallor (Pandutava) (Hb
%)
|
Sr. no. |
Pallor |
Grade |
|
1. |
Normal (>11 gm %) |
0 |
|
2. |
Mild (9-11 gm %) |
1 |
|
3. |
Moderate
(7-9 gm %) |
2 |
|
4. |
Severe (<7 gm %) |
3 |
5. Pain (Pain in abdomen / backache)
|
Sr. no. |
Body ache |
Grade |
|
1. |
No
pain |
0 |
|
2. |
Mild pain |
1 |
|
3 |
Moderate
pain |
2 |
|
4. |
Severe pain |
3 |
6.
Burning Sensation (Daha)
|
Sr. no. |
Burning sensation |
Grade |
|
1. |
No burning |
0 |
|
2. |
Occasional burning |
1 |
|
3. |
Often mild burning |
2 |
|
4. |
Severe burning |
3 |
7.
Weakness (Daurabalya)
|
Sr. no. |
Weakness |
Grade |
|
1. |
Feeling weakness Occasionally on doing Heavy work |
0 |
|
2. |
Feeling weakness After doing extra work then
routine work |
1 |
|
3 |
Feeling weakness After doing Routine work |
2 |
|
4. |
Feeling weakness Even without Routine
work |
3 |
TRIAL GROUPS
In the present clinical Study total number
of 39 patients were registered and 9 patients could not be followed So 30
patients who have completing the therapy are alienated in to 3 groups based on
the drug for the clinical trial.
Group 1- SYT (Shatavari Yashti
with Tandulodaka)
Group 2- SY (Shatavari Yashti
Yoga)
Group 3- PL (Placebo with Tandulodaka)
|
Sr.
No |
Group
name |
Dose |
Vehicle |
Time
of administration |
Duration |
|
1.(SYT) |
Shatavari Yashti Yoga |
5 gm |
Tandulodaka |
Twice
a day before meals |
2 menstrual cycle or 2 months. |
|
2.(SY) |
Shatavari Yashti Yoga |
5 gm |
- |
Twice a day before meals |
2 menstrual cycle or 2 months. |
|
3.(PL) |
Tandulodaka |
50 ml |
- |
Twice a day before meals |
2 menstrual cycle or 2 months. |
Dose design
|
Drug |
Dose |
Vehicle |
Time of administration |
Duration of treatment |
|
Shatavari Yashti Yoga |
5 - gm |
Tandulodaka |
Twice a
Day before meals |
2 month
with follow up for Next cycles |
Follow Up Study
During the maneuver all patients were regularly
analyzed and advised to attend O.P.D. after every 15 days till the end of trial
and the patients from the Camp is monitored weekly. The notable changes were
duly recorded. Laboratory investigations were carried out before and after the
commencement of trial for purpose of inclusion criteria.
Results
The results were assessed before and after the
treatment according to the positive changes in the subjective symptoms. Further
statistical analysis was done by applying Student Paired ‘t’ test and ‘P’ value was calculated by referring to
Fischer’s table at the corresponding level of degree of freedom.(3) Total
relief of the therapy was assessed on basis of percentage of relief obtained:
|
Percentage of
relief |
Effect |
|
More than 75 % |
Cured |
|
51-75 % |
Markedly
improved |
|
26- 50 % |
Moderately
Improved |
|
Less than 25 % |
No improvement
|
In the present study 39, patients were
registered out of which 9 patients dropped out during the trial and in remaining
30 patients the clinical study was completed. The study shows a marked
difference in the subduing of symptoms in all the trial groups. The main
symptoms studied were the amount and duration of bleeding, Pain, increased
Hemoglobin levels, burning sensation, and generalized weakness. Thus it is
clear from the study that the Shatavari Yashti Yoga helps in the Management of Rakta Pradara (Abnormal uterine bleeding).
EFFECT OF THE
TRIAL DRUG OF GROUP – 1 (SYT) ON VARIOUS
SUBJECTIVE SYMPTOMS
Table no. 1
Showing Statistical analysis of amount of bleeding (in no. of pads)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Amount of Bleeding (in no. of pads) |
3.9 |
0.2 |
3.7 |
0.8233 |
0.2603 |
14.212 |
P<0.0001 |
Extremely significant |
Table no. 2:
Showing Statistical analysis of Duration of Bleeding (In no. of day)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Duration of Bleeding (in no. of days) |
6.6 |
2.5 |
4.1 |
2.205 |
0.6403 |
6.403 |
0.0001 |
Extremely significant |
Table no. 3:
Showing Statistical analysis of Interval of menstrual Bleeding (In no. of day)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Intermenstrual Bleeding
(in no of days) |
11.2 |
13.8 |
-2.60 |
2.989 |
0.9452 |
2.751 |
0.0244 |
Significant |
Table no. 4:
Showing Statistical analysis of Pain
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Pain |
1.3 |
1.0 |
0.3 |
0.4030 |
0.1528 |
1.964 |
0.0811 |
Not Significant |
Table no. 5:
Showing Statistical analysis of Pallor (Pandutava)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Pallor |
9.560 |
10.680 |
-1.120 |
0.4733 |
0.1497 |
7.483 |
0.0001 |
Extremely significant |
Table no. 6:
Showing Statistical analysis of burning sensation (Daha)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Burning sensation |
0.4 |
0.0 |
0.4 |
0.5164 |
0.1633 |
2.449 |
0.0368 |
Significant |
Table no. 7: Showing Statistical analysis of
weakness (Daurabalya)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Weakness |
0.6 |
0.0 |
0.6 |
0.6992 |
0.2211 |
2.174 |
0.0239 |
Significant |
EFFECT OF THE
TRIAL DRUG OF GROUP – 2 (SY) ON VARIOUS
SUBJECTIVE SYMPTOMS
Table no. 8
Showing Statistical analysis of amount of bleeding (in no. of pads)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Amount of Bleeding |
3.4 |
1.6 |
1.8 |
1.989 |
0.6298 |
2.862 |
0.0187 |
Significant |
Table no. 9
Showing Statistical analysis of Duration of bleeding (in no. of days)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Duration of Bleeding |
5.7 |
3.1 |
2.6 |
3.373 |
1.067 |
2.438 |
0.0375 |
Significant |
Table no. 10
Showing Statistical analysis of intermenstrual
bleeding (in no. of days)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Intermenstrual Bleeding |
8.9 |
8.4 |
0.5 |
3.689 |
1.167 |
0.4286 |
0.6783 |
Not
Significant |
Table no. 11
Showing Statistical analysis of Pain
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Pain |
1.1 |
0.9 |
0.2 |
0.4216 |
0.1333 |
1.5 |
0.1679 |
Not
Significant |
Table no. 12
Showing Statistical analysis of Pallor
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Pallor |
5.120 |
5.240 |
-0.120 |
0.1398 |
0.0442 |
2.714 |
0.0239 |
Significant |
Table no. 13
Showing Statistical analysis of burning sensation
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Burning sensation |
0.4 |
0.0 |
0.4 |
0.5164 |
0.1633 |
2.4495 |
0.0368 |
Significant |
Table no. 14 Showing
Statistical analysis of weakness
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Weakness |
0.4 |
0.0 |
0.4 |
0.5164 |
0.1633 |
2.449 |
0.0368 |
Significant |
EFFECT OF THE
TRIAL DRUG OF GROUP – 3 (PL) ON VARIOUS
SUBJECTIVE SYMPTOMS
Table no. 15
Showing Statistical analysis of amount of bleeding (in no. of pads)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Amount of Bleeding |
4.1 |
1.8 |
2.3 |
1.703 |
0.5385 |
4.271 |
0.0021 |
Very Significant |
Table no. 16
Showing Statistical analysis of Duration of bleeding (in no. of days)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Duration of Bleeding |
7.4 |
4.9 |
2.5 |
1.716 |
0.5426 |
4.607 |
0.0113 |
Significant |
Table no. 17
Showing Statistical analysis of intermenstrual
bleeding (in no. of days)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Intermenstrual Bleeding |
6.4 |
7.2 |
-0.8 |
2.530 |
0.8000 |
1.000 |
0.3434 |
Not Significant |
Table no. 18
Showing Statistical analysis of Pain
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Pain |
0.5 |
0.5 |
0 |
0 |
0 |
0.000 |
P>0.999 |
Not Significant |
Table no. 19 Showing
Statistical analysis of Pallor (Pandutava)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Pallor |
5.080 |
5.080 |
0 |
0 |
0 |
0.000 |
P>0.999 |
Not Significant |
Table no. 20 Showing
Statistical analysis of burning sensation (Daha)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Burning sensation |
0.5 |
0.1 |
0.4 |
0.5164 |
0.1633 |
2.449 |
0.0368 |
Significant |
Table no. 21 Showing
Statistical analysis of weakness (Daurabalya)
|
Symptoms |
Mean |
Diff. |
SD |
SE |
't' |
P |
Results |
|
|
BT |
AT |
|||||||
|
Weakness |
0.2 |
0.2 |
00 |
00 |
00 |
0.000 |
P>0.999 |
Not Significant |
Table no. 22 Total Effect of Therapy in 30 Patients
|
Result |
No. of Patients |
||
|
Group
1 (SYT) |
Group 2 (SY) |
Group
3 (PL) |
|
|
Cured
(More
than 75%) |
06 |
01 |
03 |
|
Marked
Improvement (50
to 75% relief) |
01 |
05 |
01 |
|
Moderate
Improvement (25 to 50 % relief) |
02 |
04 |
00 |
|
No
Improvement (<
25% relief) |
01 |
00 |
06 |
DISCUSSION
v The
assessment of the results was made by adopting the standard methods of scoring the
signs and symptoms. All the observations regarding the changes in the
subjective parameters like the amount of bleeding, duration of bleeding, intermenstrual period and associated symptoms like body
pain, pallor and burning sensation and weakness were assessed clinically and
statistically.
v Effect
on Amount of bleeding: On statistical analysis the result was extremely significant in
Group 1(SYT) (p<0.0001) while in Group 3 (PL) it was very Significant and in
Group 2 (SY) it found to be Significant. Clinically also it gives the
corresponding result, the amount of bleeding is found to be reduced in all
group.
v Effect
on Duration of bleeding: On statistical analysis the result was extremely significant in Group
1(SYT) while in group 2 (SY) and 3 (PL) it is Significant.
v Effect
on Intermenstrual bleeding: On Statistical analysis the result was significant in group 1 while
in group 2 (SY) and group 3 (PL) it is not significant.
v Effect
on Pain: On
Statistical analysis the result was not
significant in any of the trial group.
v Effect
on Pallor: On statistical analysis the result was extremely significant in
group 1(SYT) while in group in group 2 (SY) it found to be Significant and 3
(PL) it was not Significant.
v Effect
on Burning Sensation: On statistical analysis the result was significant in all groups.
v Effect
on Weakness: On statistical analysis the result was significant in group 1(SYT)
and group 2 (SY) while in group 3 (PL)
it was found not be Significant.
v Overall effect of therapy:
v Out
of three Groups studied, in Group 1(SYT) marked improvement was seen in the one
Patient, moderate improvement in two patients and 6 patients were completely
cured. In Group 2(SY) marked improvement was seen in five cases, no improvement
was seen in one case, moderate improvement was seen in four cases and one
patient is completely cured. In Group 3
(PL) marked improvement was seen in one patient and moderate improvement was
not seen in any case. No improvements were seen in six cases while three
patients were completely cured.
v On
comparing the effectiveness of the three Groups it was found that the relief in
symptoms was clinically and statistically found to be significant.
v Utmost
positive findings are seen in Group 1(SYT) where quite a lot of symptoms are
completely cured rather than group 2(SY) and 3(PL) , whereas group 3 also shows
good results in curing symptoms but all symptoms are not totally alleviated.
v In
comparison with Group 3(PL); Group 2(SY) illustrates immense results in healing
the symptoms. It shows that in comparison of the results of the groups; Group
1(SYT) depicts an enormous outcome of Shatavari Yashti yoga.
v The
results clearly indicate that Shatavari Yashti Yoga is effective remedy to cure Raktapradara (Abnormal uterine bleeding).
CONCLUSION
v Shatavari Yashti
Yoga is found effective in Raktapradara (Abnormal uterine bleeding). It effectively reduced amount of
bleeding, duration of bleeding, reduces pallor, and balya (weakness is reduced).
v Overall effect of therapy concludes
that the first group of the patients who have received Shatavari Yashti Yoga with Tandulodaka
has shown highly significant results in comparison with rest of other
groups.
v Shatavari Yashti
Yoga with Tandulodaka is Non Hormonal, Cost Effective, Harmless and boon for the
Patients of Raktapradara (Abnormal uterine bleeding).
REFERENCES
1.
Kathleen A.
Oriel ans Sarina S Charger,
Abnormal Uterine Bleeding, Journal of American Family Physician, 1999, Oct 1;
60(5): 1371-1380.
2. Laxmipati Shastri Yogaratnakar Varanasi Chaukhamba
Prakashan reprint 2009,Pg no 397
3.
Mahajan B. K Methods in Biostatics
New Delhi Leipzig Press 4th Ed. 1984,Pg no.126
*****