Efficacy of Shunthi-Lodhra Churna in the Management of Asrigdara (DUB)

Objectives: The most common bleeding disorders in women are described as Asrigdara in Ayurveda, characterized by Pradirana (excessive excretion) of Raja (menstrual blood). It can be correlated to ‘Dysfunctional Uterine Bleeding’ in modern medicine. In modern medicine hormonal therapy, anti-prostaglandins & anti-fibrinolytic agents have not proven their definitive efficacy in spite of high costs; their side effects have led to hormonal imbalances. Methods: In order to overcome the above abnormalities, we conducted a clinical trial for 90 days on 30 patients of age group 18-45 yrs. We administered Shunthi Churna (2 gms.) and Lodhra Churna (3gms) mixed with Sharkara (5 gms.) i.e. total (10gms) thrice daily with cold water, after food. Two observations were taken, 1 st after 45 days of treatment and the 2 nd one after completion of treatment on various parameters like amount and duration of blood loss, inter-menstrual period, passage of clots and pain during menstruation. Results: Based on the parameters studied, we observed 60% of patients improved moderately, 36.7% showed mild-improvement, 3.3% showed marked-improvement in different symptoms. The results are highly significant on most parameters. Conclusion: Drug formulation Shunthi Churna and Lodhra Churna with Sharkara , proved to be effective in treating most of the symptoms


Introduction
Dysfunctional uterine bleeding (DUB) is defined as a state of excessive abnormal uterine bleeding without any clinically detectable organic pelvic pathology. The abnormality may be in frequency, duration or amount or combination of all (1). Normal menstrual cycle varies from 21-35 days with the bleeding phase of 4-6 days with an average loss of 35-45 ml of blood (2). Abnormal menstrual cycle is defined as any deviation from the aforesaid. The disease A srigdara explained in Ayurveda may be closely co-related with the condition Dysfunctional uterine bleeding of contemporary medical science.
According to A charya Charaka, if the menstrual cycle turns to be abnormal due to Pradirana (excessive secretion) of Raja, it is termed as Pradara (3).
According to A charya Sushruta, excessive and prolonged bleeding during menstruation or even in inter -menstrual period, different from the features of normal menstrual blood is called "A srigdara" (4).
In women it is a significant healthcare problem in the developed world (5) due to the increased stress. Between 25 -58% of women participating in the WHO study reported having excessive bleeding per vaginum in the past three months (6,7). One in 20 women aged 30-40 consults their general practitioner every year complaining of heavy uterine bleeding (8). This potentially puts them under distressing condition in their social work place. The Nidanas are responsible for A srigdara as described by Charaka are mostly Pitta V ardhaka (9). Without the influence of V ata Dosha, Yoni never gets vitiated; so all Y oni V yapads & Artava Vyapads are because of V ata Dosha (10). Acharya Charaka also explained it as a symptom of Pittavrita A panavayu (11).
Various treatments like hormonal therapy, antiprostaglandins & anti-fibrinolytic agents are available in modern health science. Many side effects have been observed because of the medication and hysterectomy lead to hormonal imbalance and psychological upset in young fertile women. So keeping this in mind we took Ayurvedic drug trial, which are non-hormonal and safe that could provide effective alternative for A srigdara.
We have selected 'Shunthi-Lodhra Churna with Sharkara' which has been mentioned in "Y oga Ratnakar" due to its contents, cost effectiveness and disease healing properties (12).
The combinatorial formulation selected for our treatment based on the following properties. Shunthi has property of Kaphavata Nashana and Shula Prashamana  (13), Lodhra has Rakta Sthambhana and Garbhasaya Shothahara properties (14) and Sharkara for its V ata, Pitta, and Rakta Doshahara properties (15). So here we attempted to evaluate the efficacy of Shunthi-Lodhra Churna with Sharkara in the management of Asrigdara w.s.r. DUB.  Method of collection of data 30 patients fulfilling the inclusive criteria were selected. Detailed history of patients was taken on predesigned specific proforma. History of present complaints with duration, associated symptoms, history of past illness (medical, surgical and drug history), personal history, menstrual history, obstetric history, contraceptive history were recorded. Other important points like marital status, socio-economic statuses were also noted.

Ultrasonography:
For condition of uterus and adnexae, any pelvic pathology and thickness of endometrium (ET).

Assessment criteria
Scoring of the symptoms was done before, during and after the study, purely on the basis of patient's explanations.   The values of both subjective and objective parameters were noted before, during (after 45 days) and after the treatment to assess the effect of therapy.

Results of Clinical Trial
The effect of the treatment was analyzed statistically by calculating the mean, standard deviation, standard error, t and p-values by using Paired t-test between the observations before treatment verses after 45 days of treatment and between the observations before treatment verses after the completion of treatment.

Aruchi
Absent 0 Present 1     Overall Effect of Treatment:

Table-12: Distribution of patients based on Overall effect of treatment
The overall effect of treatment on the different symptoms stands out as we observed 60% of patients studied have improved moderately, followed by mild improvement in 36.7% of patients. We didn't observe any patients under no improvement category. We have observed only one patient (3.3%) within marked improvement group but none in cured category.

Results and Discussion Effect of therapy on Subjective parameters of Asrigdara: Cardinal Symptoms
While analyzing the changes before, during (after 45 days) and at the end of the treatment period (90 days post-treatment) we observed that the amount of blood loss was reduced to 34% during and to 59% after the completion of treatment. Highly significant reduction was observed in duration of blood loss (36% during and 59% after) at the end of the treatment period. We observed an improvement by 33% during and 50% at the end in the inter-menstrual period. While analyzing the changes we observed reduction in passage of clots by 29% during and by 47% after the treatment. We also observed pain relief during menstruation by 41% during and 59% at the end of the treatment period in our treated patient groups (Table-2, 6-7).

Associated symptoms
In A ngamarda, 41% relief was found during and 59% after the treatment. In Daurbalya, 24% relief was observed during and 48% after the treatment. In A ruchi, 50% relief was observed during and 77% after the treatment. In Bhrama, 32% relief was found during and 50% after the treatment. In Daha, 24% relief was found during and 38% after the treatment. In Trishna, 24% relief was found during and 33% at the end of the  (Table-3, 8-9).
The observed values of TLC, DLC, ESR, BT, and CT, Platelet count, Urine and Stool examinations before treatment were within normal limits. A srigdara is not an infective disease. So TLC, DLC, ESR, urine and stool examinations might have been normal. Excessive bleeding due to any coagulation disorders were kept in exclusion criteria, so only the cases having normal bleeding time, clotting time and platelet count were included in the study.

Effect of therapy on objective parameter of Asrigdara
Before, during and after the treatment period Hb% was analyzed, and we observed highly significant improvement in the Hb% after the end of the investigation period of treatment (Table-4, 10-11).

Overall effect of therapy:
The total effect of treatment in our treated patients, on the basis of criteria of assessment adopted, has shown that 60% of patients studied have improved moderately, followed by mild improvement in 36.7% of patients. We didn't observe any patients under no improvement category (Table-12). We have observed only one patient (3.3%) within marked improvement category but none in cured category.

Probable mode of action of the drugs in treating Asrigdara: Shunthi:
Acharya Charaka has explained Asrigdara is a symptom of Pittavrita A panavayu and A charya Sushruta mentioned it under Pitta samyukta A pana (16), Katu Rasa, Ushna Virya, Dipaniya, Vatanulomaka, Vibandha Nashaka (17,18), properties of Shunthi helps to normalize the movement of A pana V ayu that has get obstructed by Pitta in the A rtavavaha Srotasa. Due to Dipaniya and Pachaniya properties (19) it regularizes the function of Y akrita, hence metabolism of oestrogen becomes normal. So we hypothesized to see the positive effect in regulating the menstrual cycle and also the subsidation of symptoms like A jirna, Aruchi (20) due to Amadosha Pachana.
Previous clinical research have shown that ginger, one of the forms of Shunthi can reduce symptoms of dysmenorrhea in some women when taken in a specific extract composition (Zintoma, Goldaru) (21). The extract of ginger blocks the formation of inflammatory compounds such as thromboxane, leukotrine and prostaglandins, thus acts as an anti-inflammatory substance (22). Hence,we believe this could have positive regulatory effect on dysmenorrhea. Due to antiinflammatory effect it is expected to pacify the pelvic congestion (high vascularity), thus the amount of blood loss gets reduced.

Lodhra:
In the pathogenesis of A srigdara, Chala Guna of Vata Dosha, Sara and Drava Guna of Pitta Dosha (23) increases the amount of blood. Hence this drug might affect the Sara and Drava Guna of Pitta Dosha with the help of Ruksha, Laghu Guna and Kashaya Rasa (24,25). So this could be the reason in reducing the amount of bleeding. Laghu, Ruksha Guna having Kapha-Pitta Shamaka (26) and Shoshana property (27) helps in Sroto Shodhana. Production of oestrogen is also increased by the use of fatty products in diet. Fatty materials have shown to increase the cholesterol in the blood circulation. Cholesterol is the precursor of all steroidal hormones; especially in female it is responsible for more production of oestrogen (28). Kapha Shamaka and Lekhaniya Karma are probably carried out by Laghu and Ruksha Guna (29) of Lodhra, therefore it decreases the production of oestrogen leading to reduced hyperplasia of endometrium.
Biochemically Lodhra contains 3monoglucofuronoside of 7-methyl leucopelagonidin, which makes it glycosidic in nature, which also exerts vaso-constrictive action and reduces the permeability of cell membrane. It has also shown anti-fibrinolytic activity. Ethanolic extract from bark also acts as an analgesic, anti-inflammatory and antioxidant (30). These properties are considered helpful in reducing the amount of bleeding.
Trishna results from the Rakta Kshaya i.e the loss of fluids from the body. Anaemic condition results in neuritis, which expresses itself as Daha. Due to Grahi Guna (vaso-constrictive action) of Lodhra is expected to have positive effect in curing Trishna and Daha by reducing the blood loss (31). It also pacifies Daha and Trisha due to its Sheeta Virya (32).
In a published in-vivo study, Lodhra has been shown to be useful and have an effect on regularizing menstrual cycle and also in ovulation (33). In another published report the effect of ethanolic extract of Symlocos recemosa bark powder in treating female reproductive dysfunction in a rat experiment showed significant decrease in the duration of pro-estrous phase and a significant increase in the duration of estrous, metestrous, diestrous phases (34).
Another report to test the hepato-protective effect of Symplocos racemosa Roxb, showed significantly reduction on the levels of hepatic enzymes and total bilirubin (35). In A srigdara, Yakrita and Pliha get vitiated. So the hepato-protective activity (36) of Symlocos recemosa regulates the conjugation and metabolism of female hormones, which results in maintaining a normal menstrual cycle. Bhrama occurs due to blood loss, the haemostatic effect (Raktasrava nashaka of Lodhra might have effect in controlling Bhrama).
The main component of Lodhra is large amount of loturine alkaloid and it also contains à-spinosteral.
Spinosteral had been shown to have anti-inflammatory activity on isolated guinea pig ileum. It is suggested that Lodhra might have influenced the endometrial prostaglandin apparatus, thereby acting effectively in the control of dysfunctional uterine bleeding (37).

Sharkara
Due to Madhura Rasa, Sheeta Virya, Madhura Vipak (38,39) Sharkara pacifies Pitta and Rakta, which is the main physiological factor in producing A srigdara. Sharkara is very sweet and increases the taste, mitigates V ata, Pitta, Rakta, burning sensation, fainting, vomiting and fever (40). Madhura Rasa increases better palatability. Due to Madhura Rasa it acts as Balya, Bringhaniya, so the symptoms Daurbalya might have improved (41). It pacifies 'Raktapitta (42), A charya Sushruta also mentioned Asrigdara to be treated just like treatment of Raktapitta. Because of its Sheeta V irya (43) property, it pacifies Daha, Trisha, and Raja. So it might have effect to normalize the abnormal menstrual cycle. Bhrama, Murchha etc. occur due to cerebral hypoxia resulting from the reduced oxygen carrying capacity of blood. Due to reduction in the amount of blood loss, it could have helped in curing Bhrama.

Conclusion
The main principle of the management of Asrigdar is deepana-pachana, Agni vardhana, rakta sthapana etc (44). Present research work was on the basis of observations and results of trial drug, pharmacological virtue and chemical constituents. The drugs Shunthi Churna and Lodhra Churna with Sahapana Sharkara possess Rakta Stambhaka Vatapitta Shamaka & Vatanulomaka properties. Our tested drug combination has shown to be effective in excessive and prolonged bleeding by reducing both amount and duration of blood loss, normalizing intermenstrual period and also for relief in pain and improvement in consistency of blood. The drug combination also found to reduce the associated symptoms like A ngamarda, Daurbalya, A ruchi, Daha, Bhrama and Trisha.
From the above findings and observations, we can conclude that the drug formulation Shunthi Churna and Lodhra Churna with Sharkara, proved to be effective in treating most of the symptoms of A srigdara.