Clinical study on Siddha medicine ‘’Kadukkai chooranam’’ in the management of Menorrhagia.
1. Dr.M.Mohanapriya, PG alumna, Department of Maruthuvam, Government siddha medical college, Arumbakkam, Chennai - 106
2.Prof Dr.K.Kanakavalli MD(S), Director General, Central Council for Research in Siddha, Arumbakkam, Chennai - 106
3.Prof Dr.P.Parthibhan MD(S), Joint Director, Directorate of Indian Medicine & Homeopathy, Arumbakkam, Chennai -106
Abstract
Uterine related disorders or menstrual associated disorder are common in one in ten women who are in their reproductive age. Menorrhagia is one of the most common and significant gynaecological problems and is seen in about 10-15% of women. Menorrhagia is a major clinical symptom in gynaecological diseases that affect 1 in 5 women worldwide. World Health Organization (WHO) identified the prevalence of three-month severe bleeding as 8–27% of women. Siddha is one of the ancient systems of medicine known to mankind. The siddhar Yugi muni, well known as Father ofSiddha pharmacology classified 4448 diseases in his literature Yugi vaithiya chinthaamani and as per the literature the clinical features of Pitha Perumbadu was found to be similar to that of Dysfunctional Uterine Bleeding. Through siddha, the Kadukkai chooranam were used to treat gynaecological diseases. Clinical study conducted among 20 females visited our hospital. The parameters like haemoglobin, bleeding time, clotting time, and pad usage were noted before and after the treatment. Along with associated symptoms like excessive bleeding, prolonged menstrual bleeding, intermittent blood clot, tiredness, headache, lower abdominal pain, giddiness and low back ache noted before and after the treatment. The study shows significant therapeutic efficacy and the scientifically the bleeding time, clotting time, and pad usage reduction and increase of haemoglobin etc.
Keywords
Menorrhagia, Dysfuntional uterine bleeding, menstrual bleeding.
Introduction
Abnormal Heavy or irregular menstrual bleeding without an notable lesion is mainly due to an imbalance of the various hormones which have a regulatory effect on the menstrual cycle.(1) Another cause of heavy menstrual bleeding with no pelvic pathology is the presence of an acquired or inherited bleeding disorder.(2) The haemostatic system has a central role in controlling the amount and the duration of menstrual bleeding, thus abnormally prolonged or profuse bleeding does occur in most women(3) affected by bleeding disorders. Whereas irregular, pre‐menarche or post‐menopausal uterine bleeding is unusual in inherited or acquired haemorrhagic disorders, severe acute bleeding and heavy menstrual bleeding at menarche and chronic heavy menstrual bleeding during the entire reproductive life are common.(4)
Uterine related disorders or menstrual associated disorder are common in one in ten women who are in their reproductive age. Menorrhagia is one of the most common and significant gynaecological problems and is seen in about 10-15% of women.(5) It strikes at the core of a women’s psyche affecting her physical, mental and spiritual health. A woman feels hard to talk about her problems and experience, unless they are fellow sufferers.
Menorrhagia is a major cause of gynaecological diseases that affect 1 in 5 women worldwide of their reproductive age; 9–14% of women in their reproductive age lose 80 mL blood in each cycle.(6) This proportion shows similar frequency in developing countries as well. In a study conducted among the women of rural India, 60.6% were having menstrual disorders as one of the common gynaecological diseases. In a multi-centric country study, World Health Organization (WHO) identified the prevalence of three-month severe bleeding as 8–27% of women.(7)
The characteristics of menorrhagia are excessive flow at the time of an expected period, blood loss of 80ml or more since upper limit of normal menstruation is taken as 80 ml per menses, abnormality in bleeding which denotes the present of intermittent shedding of blood clots. Menorrhagia is one of the commonest causes of Iron deficiency Anaemia. In which 9-14% of women lose more than 80ml per period and 60% of these women are actually anaemic.(8)
In between menarche and menopause, roughly 400-500cycles occur in an average female menstruation. The factors like, interval or cycle length, the duration of flow and the amount of blood loss are major characteristics in this case. Duration of flow and amount of blood loss are causes for concern in menorrhagia.(9)
The aetiology is purely hormonal and the hypertrophy and hyperplasia of the endometrium are induced by a high titre of oestrogen in the circulating blood.(6) Progesterone is responsible for secretion of PGF2 alpha in anovulatory cycles; absence of progesterone causes absence or low level of PGF2 alpha and can cause menorrhagia. Tissue plasminogen activator (TPA), a fibrinolytic enzyme is increased and this increased fibrinolysis causes menorrhagia.
Aim of this study
The Aim of this study is to evaluate the effectiveness of Siddha medicine in the management of Menorrhagia
Methodology
Study Design
The study was approved by the Ethical committee of GSMC, Chennai and registered in Clinical trials registry of india (Trial REF/2016/06/011550). It is a descriptive, open clinical study conducted among 20 females visited hospital of Government Siddha medical college, Chennai.
Selection of cases
20 female cases were selected who are in reproductive age group [18 to 45years] were taken from Hospital. Before selecting all the cases were carefully examined for proper diagnosis and comorbid, systemic illness were ruled out. All the cases were included based on inclusion and exclusion criteria. All the necessary investigations and follow-up were done properly with intervals.
Follow-up
The patients were followed for the treatment up to 2-3 consecutive menstrual cycles.
Inclusion and Exclusion criteria
The female subjects having excessive menstrual bleeding, with regular menstrual cycles (regular shedding), Prolonged duration, Presence of blood clots, and anaemia were included for the study. The female subjects having age group-less than 18yrs and more than 45yrs, bleeding disorders, malignancies like carcinoma of cervix, vagina and uterus, intrauterine contraceptive devices [IUCD] users were excluded from the study.
Therapeutic Medicine
Fruit rind of 100 (Kadukkai) Terminalia chebula is grinded using fresh leaf juice of (Adathodai) Justicia adathoda and dried well. This procedure is repeated for 14 times. Adult human dose is 1gm thrice a day with honey from the first day of menstrual cycle upto bleeding stops with a regular review for each 7 days. The treatment is given for 3 consecutive cycles. Kadukkai chooranam was taken from the literature Agathiyar attavanai vaagadam used to treat Dysfunctional Uterine Bleeding (Menorrhagia).
Evaluation of Clinical Parameters
A detailed history of patient’s history, complaints, signs and symptoms, Number of pads, haematological observations, treatment response, bleeding and clotting times were noted. History of any past illness, personal history, menstrual and obstetric history are noted.
Statistical analysis
We analysed the data obtained from the study using Microsoft excel 2007 and evaluated them through frequency and percentage.
Results
Table 1. Signs and Symptoms of selected subjects
SIGNS AND SYMPTOMS |
BEFORE TREATMENT |
AFTER TREATMENT |
||
NO.OF CASES |
PERCENTAGE |
NO.OF CASES |
PERCENTAGE |
|
EXCESSIVE MENSTRUATION |
20 |
100% |
1 |
5% |
PROLONGED MENSTRUATION |
20 |
100% |
0 |
0% |
PRESENCE OF BLOOD CLOTS |
20 |
100% |
0 |
0% |
LOWER ABDOMINAL PAIN |
13 |
65% |
1 |
5% |
LOW BACK ACHE |
8 |
40% |
2 |
10% |
TIREDNESS |
20 |
100% |
0 |
0% |
GIDDINESS |
11 |
55% |
1 |
5% |
HEAD ACHE |
2 |
10% |
0 |
0% |
Figure. 1 Signs and symptoms during treatment
In this study, Before the treatment the bleeding nature was excessive and after treatment it was drawn from 100% to 5%, prolonged menstrual bleeding drawn from 100% and presence of blood clots from 100% drawn from 100% and tiredness from 100% and head ache from 10% were drawn to 0%, lower abdominal pain from 65% and giddiness from 55% were drawn to 5%, low back ache from 40% drawn to 10%.
Number of Pads
Table 2. No. of Pad usage before treatment
NO.OF PADS/3 DAYS |
NO.OF CASES/20 |
PERCENTAGE |
ABOVE 20 PADS |
2 |
10% |
16-20 PADS |
5 |
25% |
11-15 PADS |
12 |
60% |
BELOW 11 PADS |
1 |
5% |
Table 3. No. of Pad usage after treatment
NO.OF PADS/3 DAYS |
NO.OF CASES/20 |
PERCENTAGE |
ABOVE 20 PADS |
1 |
5% |
16-20 PADS |
1 |
5% |
11-15 PADS |
5 |
25% |
BELOW 11 PADS |
13 |
65% |
Figure 2. Number of Pads Before and After Treatment
Before treatment, 10% female used more than 20 pads and after the treatment it was reduced to 5%. The patients using 16-20 pads were drawn from 25% to 5%, patients using 11-15 pads were drawn from 60% to 25% and patients using below 11 pads were increased from 5% to 65%. It is an remarkable change to be note that, more than 65% of patients using pads less than 11 which was considered as outcome of this treatment.
HAEMATOLOGICAL OBSERVATION
Table 4. Haematological observation before treatment
HAEMOGLOBIN LEVEL |
NO.OF CASES/20 |
PERCENTAGE |
10-12 gms |
3 |
15% |
8-10 gms |
13 |
65% |
6-8 gms |
4 |
20% |
Table 5. Haematological observation after treatment
HAEMOGLOBIN LEVEL |
NO.OF CASES/20 |
PERCENTAGE |
10-12 gms |
14 |
70% |
8-10 gms |
5 |
25% |
6-8 gms |
1 |
5% |
Figure 3. Haemoglobin percentage before and after treatment
After treatment 6-8 gms of Hb level were noticed in 5% of patients, 8-10gms of Hb were noticed in 25% of the patients and 10-12 gms of Hb level were noticed in 70% of the patients. Linearity line in after treatment, show gradual incline from low to high level.
Table 6. Gradation of Treatment Outcome
GRADE OF RESULTS |
NO.OF CASES/20 |
PERCENTAGE |
GOOD RESPONSE |
13 |
65% |
MODERATE RESPONSE |
5 |
25% |
FAIR RESPONSE |
2 |
10% |
Figure 4. Grading of treatment outcome
Good response of treatment was about 65% and moderate response of treatment
was about 25% and fair response was in 10% of the patients. Overall this
study shows good outcome with this. Numbers of pads used by the patients
were gradually reduced after the treatment. Bleeding time and clotting time
were gradually reduced after the treatment.
NUMBER OF PADS USED BY THE PATIENTS
BEFORE AND AFTER TREATMENT
Table 7. Number of pad usage before and after treatment
S.NO |
OP.NO |
NAME OF THE PATIENT |
NO OF PADS FOR A CYCLE |
|
BT |
AT |
|||
1. |
7672 |
Mrs. Jayanthi |
16 |
10 |
2. |
7636 |
Ms. Vinothini |
22 |
13 |
3. |
7167 |
Ms. Benazir |
14 |
10 |
4. |
8425 |
Mrs. Sentamil |
10 |
7 |
5. |
9489 |
Mrs. Kalaiselvi |
15 |
10 |
6. |
678 |
Mrs. Yasmin |
13 |
8 |
7. |
823 |
Mrs. Sundari |
18 |
11 |
8. |
949 |
Mrs. Renuka |
14 |
10 |
9. |
7737 |
Mrs. Baskamalar |
26 |
21 |
10. |
9557 |
Mrs. Valarmathy |
11 |
8 |
11. |
1570 |
Mrs. Logeshwari |
22 |
13 |
12. |
1712 |
Ms. Suganya |
13 |
9 |
13. |
8429 |
Ms. Archana |
15 |
10 |
14. |
1620 |
Mrs. Bharathi |
15 |
11 |
15. |
4021 |
Mrs. Meenakshi |
16 |
11 |
16. |
3162 |
Mrs. Sumathi |
20 |
12 |
17. |
5057 |
Mrs. Jeyanthi |
12 |
8 |
18. |
5186 |
Mrs. Mala. |
14 |
10 |
19. |
3116 |
Mrs. Kala |
13 |
9 |
20. |
7531 |
Mrs. Uma maheshwari |
15 |
10 |
HAEMOGLOBIN LEVEL
Table 8. Haemoglobin level before and after level
OP.NO |
NAME OF THE PATIENTS |
HAEMOGLOBIN LEVEL IN GMS/100ML OF BLOOD |
|
BT |
AT |
||
7672 |
Mrs. Jayanthi |
8.0 |
9.2 |
7636 |
Ms. Vinothini |
6.4 |
8.4 |
7167 |
Ms. Benazir |
8.2 |
9.6 |
8425 |
Mrs. Sentamil |
9.0 |
10.2 |
9489 |
Mrs. Kalaiselvi |
9.6 |
10.5 |
678 |
Mrs. Yasmin |
10.0 |
10.8 |
823 |
Mrs. Sundari |
9.2 |
10.5 |
949 |
Mrs. Renuka |
9.8 |
10.5 |
7737 |
Mrs. Baskamalar |
7.0 |
7.9 |
9557 |
Mrs. Valarmathy |
10.8 |
11.4 |
1570 |
Mrs. Logeshwari |
9.4 |
10.6 |
1712 |
Ms. Suganya |
9.8 |
10.5 |
8429 |
Ms. Archana |
9.4 |
10.2 |
1620 |
Mrs. Bharathi |
9.2 |
10.2 |
4021 |
Mrs. Meenakshi |
10.6 |
11.2 |
3162 |
Mrs. Sumathi |
8.0 |
9.4 |
5057 |
Mrs. Jeyanthi |
9.0 |
10.1 |
5186 |
Mrs Mala. |
9.8 |
10.5 |
3116 |
Mrs. Kala |
8.4 |
9.2 |
7531 |
Mrs. Uma maheshwari |
8.6 |
10.4 |
BLEEDING TIME AND CLOTTING TIME
Table. 9 Bleeding and clotting time of patients
OP.NO |
NAME OF THE PATIENTS |
BLEEDING TIME min’ sec” |
CLOTTING TIME min’ sec” |
|||
BT |
AT |
BT |
AT |
|||
7672 |
Mrs. Jayanthi |
2’54” |
2’20” |
4’48” |
5’12” |
|
7636 |
Ms. Vinothini |
2’10” |
2’22” |
4’49” |
4’14” |
|
7167 |
Ms. Benazir |
3’10” |
2’54” |
4’55” |
4’17” |
|
8425 |
Mrs. Sentamil |
2’12” |
2’10” |
6’42” |
5’40” |
|
9489 |
Mrs. Kalaiselvi |
3’27” |
2’44” |
6’02” |
6’41” |
|
678 |
Mrs. Yasmin |
2’36” |
4’10” |
4’52” |
5’25” |
|
823 |
Mrs. Sundari |
3’27” |
2’10” |
5’24” |
4’18” |
|
949 |
Mrs. Renuka |
2’10” |
3’10” |
5’44” |
5’10” |
|
7737 |
Mrs. Baskamalar |
3’08” |
2’58” |
6’34” |
6’02” |
|
9557 |
Mrs. Valarmathy |
2’42” |
2’40” |
5’38” |
4’51” |
|
1570 |
Mrs. Logeshwari |
1’48” |
2’18’ |
5’22” |
5’32” |
|
1712 |
Ms. Suganya |
2’40” |
2’08” |
4’36” |
3’50” |
|
8429 |
Ms. Archana |
3’36” |
2’10” |
5’44” |
5’10” |
|
1620 |
Mrs. Bharathi |
2’10” |
1’54” |
3’55” |
3’10” |
|
4021 |
Mrs. Meenakshi |
2’54” |
2’06” |
3’24” |
3’20’ |
|
3162 |
Mrs. Sumathi |
2’10” |
1’46” |
5’10” |
4’51” |
|
5057 |
Mrs. Jeyanthi |
3’09” |
2’04” |
5’48” |
5’16” |
|
5186 |
Mrs Mala. |
2’24” |
2’02” |
5’40” |
4’39” |
|
3116 |
Mrs. Kala |
2’54” |
1’59” |
6’24” |
5’15” |
|
7531 |
Mrs. Uma maheshwari |
2’55” |
2’02” |
6’10’ |
5’39’ |
CONCLUSION
The Kadukkai Chooranam poses good styptic activity in terms of reducing bleeding and clotting time. The menstrual bleeding was gradually reduced and the symptoms like excessive bleeding, prolonged menstrual bleeding, intermittent blood clot, tiredness, headache, lower abdominal pain, giddiness and low back ache reduced drastically. After the treatment, the pad usage more than 20 has reduced upto 11 pads. Associatively haemoglobin level was raised more than 11gm/dl. Overall, this study shows good and significant therapeutic efficacy with this drug.
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