RESEARCH AND PUBLICATIONS

TOPIC: Evaluation of the efficacy of Godanti Bhasma in shweta pradar with special reference of leucorrhoea a clinical study.

 Abstract: – Evaluation of the efficacy of Godanti Bhasma in shweta pradar with special reference of leucorrhoea a clinical study.

• Introduction: Godanti on of the mineral drug. Godanti bhasma was prepared by steaming in nimbu swarsa. then subjected to ‘Gaja Puta’ To prove standed for antimicrobial activity anti-fungal properties.

• Method: Godanti Bhasma analysis and particle size were noted by ICP-AES, Godanti Bhasma given in three grouphs upto 30 days

• Conclusion: 60 patients are taken for study

• 20 patients were administering godant bhasma with lukewarm water – Standard group.

• 20 patients were administer lukewarm water – Control group.
• 20 patients were administer Azostatkit given –

Introduction:

                       Ayurvedic medicines are gaining popularity and acceptance in the developed countries due to the failure of the allopathic system of medicine in various chronic aliments.

                         The adverse effects of chemical drugs and other hazards of allopathic system .The Ayurvedic formulation are well accepted inter world but need scientific and based on clinical data format global standards.

                        Shwetapradara (Leucorrhoea) is explained in detail by Ayurvedic scholars in which per vaginal white discharge are observed as a predominant symptom with its associated local and systemic manifestation. In most of the texts Shwetapradara (Leucorrhoea) is explained under yonivyapat chikitsa.³ In present days more than 40 % of Indian woman suffer from the same complaint.

                                      Leucorrhoea is a common disease occurring to many women and form about 10 % of cases attending gynecological clinic.¹ In under developed countries majority of women complaint of abnormal vaginal discharge, Low immunity, fungal and bacterial infections, unhygienic living conditions are most important factors for excessive vaginal discharge and decreased vaginal pH leading to vaginal infections; rather all the time vagina is itself naturally self sterilizing organ.²

More than 70% of patients populations of Shwetapradara (Leucorrhoea) are obtained in rural areas. In developing countries like India ill health and unhygienic living conditions are observed commonly. Many cases were observed unreported to practitioners. It is very important to distinguish between non-infected and infected vaginal discharge. Non-specific vaginal discharge may be related to the presence of foreign material such as tampons IUCD etc. producing a profuse vaginal white discharge in specific vaginitis. The most common infections in woman are trichomonas vaginilis, Candida albicans and bacterial vaginosis. If this is neglected, may lead to severe damage to the internal and external genital organs.²

          Modern Medicines like Clotrimazole, Fluconazole, Itracanazole, Secnodazole, Metronidazole, Tinidazole, Orinidazole etc. are wide range of antibiotics commonly used to treat leucorrhoea. But side effects like nausea, gastric upset, skin rashes, urticarea, lower abdominal pain, diarrhea etc. are noted. At the same time it is observed that these drugs are found to be effective in local manifestations but associated complaints like body ache, leg cramps, anaemia and general weakness etc. remain untreated. As patients and practitioner are in need of a medicine, which can treat the main and associated symptoms manifested in Shwetapradara (Leucorrhoea), Godhanti Bhasma along with   Lukewarm water as anupana is considered to be effective in Shwetapredara without untoward effects as seen from a pilot clinical study conducted at Badami  Ayurvedic College OPD and different practitioners outside. The standard quality of Godhanti Bhasma manufactured by various pharmaceutical industries is questionable, so it encouraged to undertake this project and an attempt was made with this project on physicochemical analysis of Godhanti Bhasma and assessment of its clinical efficacy in Shwetapredara (Leucorrhoea)

1. a) to establish standards for standardization of Godhanti Bhasma.
2. b) to assess clinical efficacy of Godhanti Bhasma in Shwetapradara (Leucorrhoea) .
3. c) to provide a safe, alternative and economic medicine in Shwetapradara (Leucorrhoea).

                 Most of therapeutic measure and medicine in the treatment Shwetapredara have been unsatisfactory or very expencive and difficult so Godhanti Bhasma having antimicrobial activity

And anti funguls activity and anti-inflammatory properties in combination found as an effect medicine in Shwetapredara an was made in this study.

Materials and methods:

   Selection of patients:

                                 Patients attending OPD and IPD of shri veerpulikeshi rural ayurvedic hospital badami, fulfilling the diagnostic and inclusion criteria of shwetpradara werw selected and registered randomly irrespective of age sex or religion.

Criteria for Diagnosis:

                               Patients having signs and symptoms of shwetpradara were selected percent study. Detailed history was taken and physical examination was according special proforma incrporatis the signs and symptoms of the disease.

Symptoms-chief complaints

1. White discharge p.v
2. Foul smell
3. Vaginal itching
4. Low back pain
5. Body ache
6. Lower abdominal pain
7. General weakness
8. Leg cramps/weakness of lower limb

Inclusive and Exclusive Criteria:

Inclusion:

1. Patients with Shwetapradara (Leucorrhoea) were selected according to the

clinical features mentioned in ancient Ayurvedic text and supported with investigations.

1. Married patients between 20 to 40 age group.
2. Those who are having regular menstrual cycle.
3. Patients who are not having chronic PID, cervical erosions, Carcinomatic      

          growth of genital organ. 

Exclusion:

1. Patients below 20 years and above 40 years.
2. Those having chronic PID, cervical erosions, Carcinomatic growth of
   genital organ.
3. Patients with irregular menstrual cycle.

Investigations: Parameters of Shwetapradara

1. HB%
2. D.R.L Test
3. Urine consulate
4. Pap smear test

              Before treatment all patients who are selected for study.

Diet and Restrictions:

1. Basic diet vegetarian and non vegetarian was noted.
2. General Physical examination to report once week during the treatment to record change in clinical symptoms up to 30 days and laboratory investigations reports were collected before and after treatment.

Method of administration of drugs:

1. Group I 20 patients administration of Godhanti Bhasma
2. Dose-250 mg / 2 time BD
3. Vehicle-Lukewarm Water
4. Duration-30 days

Criteria for assessment:

                    The efficacy of the trial drug was analyzed in terms of the relief produced in symptoms before treatment.

DISCUSSION

Clinical study was conducted to assess the clinical efficacy of Godanti Bhasma in Shwetapradara. 60 patients of Shwetapradara, Godanti Bhasma, Lukewarm water and Azostat kit formed as materials for the clinical study.

60 patients of Shwetapradara were randomly selected and distributed 20 in each group. G.B along with Lukewarm water was administered to 20 patients in Group I for 30 days, only Lukewarm water to 20 patients in group II for 30 days as control and Azostat kit (single dose) to 20 patients in group III.

Patients were asked to report at the interval of 7 days and changes in symptoms were noted Blood for % of Hb and VDRL, Urine complete and pap smear test were recorded before and after treatment.

Group I – P/V white discharge was absent in 19 (95%) of patients. This may be due to Godanti Bhasma alone contents Calcium & Sulfer which checks the vaginal secretions and reduces the cell permiability and this helps in reducing the P/V white discharge.

Godanti Bhasma may act in such a way by maintaining infection.

 Foul smell was absent in 11 (100%) of patients. This may be due to ingredients of G.B or responsible for maintaining vaginal pH as acidic, checks the growth of micro – organisms and theirby preventing foul smell.

Vaginal itching was absent in 15 (100%) of patients. This may be due to G.B. which checks the infection by their antifungal, antibacterial, antiin flammatory and vasoprotective action and being antiseptic in nature heals the mucosal erosions and checks the small haemorrhages.

General weakness was relived in16 (94%) of patients due to the effect of Calcium.

          Bodyache and Low back pain were relieved in 16 (94%) and 19 (100%) of patients respectively. Which may be due to Calcium.

          Leg cramps was relieved in 18 (100%) of patients which may be due to Calcium.

In Group II :   Symptoms such as p/v white   discharge, Foul smell vaginal itching, Low backpain, bodyache, lower abdominal pain and General Weakness leg cramps/weakness of lower limbs were   not relieved.  Hence   all   patients were shifted to group I after one week.

In Group III : patients were treated with Azostat kit relieved from the symptoms by the following sequence. Foul smell was absent in 17 (100%) patients, Vaginal itching in 7 (100%) patients, P/V white discharge in 18 (90%) patients, Lower abdominal pain in 15 (83%) patients, Low back pain in 16 (80%) patients, General weakness in 15 (75%) patients, Bodyache in 14 (70%) patients and Leg cramps / weakness of lower limbs in 9 (47%) patients.

The above symptoms relieved may be due to selectively high activity against anaerobic organisms.

Statistical test :

1. Foul smell:

    Group-I V/s Group-II : There was significant difference in between the groups

    at p < 0.001 (x² = 31.0). 

    Group I Vs Group III : In both groups significant relief of Foul smell was noted   

    i.e in  Gr I (100%) and in Gr III (100%). therefore no statistical difference  was

    found.                                         

1. Vaginal Itching :

     Group I Vs Group II : There was significant difference in between the groups

     at p < 0.001 (x² = 33.0)  Group I Vs Group III : In both groups significant relief  

     of Vaginal Itching was noted i.e in Gr I (100%) and in Gr III (100%). therefore    

     no statistical significance difference  was found.

1. Low back pain :

     Group I Vs Group II : There was highly significance in between the groups

     at p < 0.001 (x² = 39.0).

     Group I Vs Group III : There was significant difference in between the groups

     at p < 0.04 (x² = 4.34). 

1. Leg cramps / weakness of lower limbs :

    Group I Vs Group II : There was highly significance in between the groups

     at p < 0.001 (x² = 24.873). 

     Group I Vs Group III : There was highly significance in between the groups

      at p < 0.001 (x² = 12.982).

1. p/v white discharge :

    Group I Vs Group II : There was highly significance in between the groups

    at p < 0.001 (x² = 28.97).

   Group I Vs Group III : In both groups significant relief of p/v white discharge

   was noted i.e in Gr I (95%) and in Gr III (90%). therefore no statistical difference     

   was found.       

1. General weakness :

     Group I Vs Group II : There was significance difference in both groups

     at p < 0.001 (x² = 28.326). 

     Group I Vs Group III : In both groups significant relief of General weakness    

    was noted i.e in Gr I (94%) and in Gr III (75%). therefore no statistical  

    difference was found.   

1. Bodyache :

    Group I Vs. Group II : There was highly significance in between the groups

    at p < 0.001 (x² = 26.027).

   Group I Vs Group III : In both groups significant relief of Bodyache was noted   

   i.e in Gr I (94%) and in Gr III (70%). therefore no statistical difference was   

   found.    

1. Lower abdominal pain :

    Group I Vs. Group II : There was highly significance in between the groups

    at p < 0.001 (x² = 27.536).

   Group I Vs Group III : In both groups significant relief of Lower abdominal pain  

   was noted i.e in Gr I (80%) and in Gr III (83%). therefore no statistical  

   difference was found. 

Pap smear test:

       In Group I : Out of 20 Leucorrhoea patients 13 (65%) were observed infective,7 (35%) were non infective. Out of 13 patients Trichomonas vaginalis in 3 (15%), before the treatment. After the treatment Trichomonas vaginalis was negative in all the patients 3(100%), Bacterial infection was negative in 3 (75%) patients Candida albicans was negative in patients 5 (100%) and mixed infection

in 0(0%) patients.

In Group II : Out of 20 Leucorrhoea patients 16 patients (80%) were observed

infective and 4 patients (20%) were non infective. Luke-warm water was administered as control group but Patients did not respond to treatment, so shifted to Group I after one week.                

      In Group III : Out of 20 Leucorrhoea patients 16 patients (80%) were infective and 4 (20%) non infective Trichomonas vaginalis was observed in 4 patients (20%), Bacterial infection in 9 patients (45%), Candida albicans was in 3 patients (15%), mixed infection was not present in any patients before treatment. After treatment Trichomonas vaginalis was negative in all patients (100%), Bacteria infection was negative in 8 patients (99%), Candida albicans was negative in all patients (100%).

       Pap smear:

       Group I Vs. Group II : There was highly significance in between the groups after 30 days of treatment at p < 0.001 (x² = 21.812). Group I Vs Group III : There was no significant difference between the groups after 30 days of treatment as p > 0.422 (x² = 0.645).   

During the treatment no side effects were observed in 100% of patients in Group I. Where as in Group III more than 50 % of patients had Gastritis, General weakness and leg cramps.

In modern medical science Tinidazole + Flucanozole (Azostat kit) is drug of choice in Leucorrhoea. It is observed that it has been effective in local manifestations and associated complaints like bodyache, low back pain, General weakness, leg cramps, anaemia remains untreated. Again it requires the combination of medicines i.e., Analgesics and anti-inflammatories, General tonics, Appetisers etc. But todays medical practitioners and patients are in need of a medicine which can cover the prime and associated symptoms manifested in leucorrhoea.

As Godanti Bhasma having antifungal, antibacterial, and anti-inflammatory and it covers the therapeutical validity of multiple drugs prescribed in Leucorrhoea. Cost effective therapeutic activity and safety concerned Godanti Bhasma may be considered as drug of choice in Leucorrhoea.

CONCLUSION

• 60 patients formed the study population. 20 patients were administered Godanti Bhasma with Lukewarm water in Group I, 20 patients were given Lukewarm water as a control in Group II and 20 patients were given Azostat kit in Group III.
• Maximum number of patients were seen in Age group of 22 to 40 years.
• Maximum number of patients were of low socio-economic status, i.e in Group I 11 (55%), in Group II 14 (70%) and in Group III 12 (60%).
• Maximum number of patients were of unhygienic living condition i.e in Group I 15 (75%), in Group II 18 (90%) and in Group III 13 (65%)
• In Group I symptoms like foul smell, vaginal itching, Low back pain, Leg cramps or weakness of lower limbs were relieved in 100% of patients and other symptoms were relieved in 80-95% of patients.
• Symptoms were not relieved in Group II patients. Hence all patients were shifted to Group I after one week.
• In Group III symptoms like foul smell, Vaginal itching, P/V white discharge were relieved in 90-100% of patients and other symptoms were relieved in

70-80% of patients.

• Godanti Bhasma has demonstrated significant relief of symptoms in comparision to Group II and Group III.
• Godanti Bhasma was found effective in Trichomonal vaginalis, candida albicans 100%, in Bacterial infection 75% and the result was significant.
• Significant antifungal, antibacterial activity of Godanti Bhasma was noted and comparable to standard drug Azostat kit.
• After 30 days of treatment most of the infective cases of Leucorrhoea in Group I and Group III were found negative and it was significant.
• Antifungal, antibacterial, anti-inflammatory and haematenic properties are noted in Godanti Bhasma.
• A single Godanti Bhasma covers the therapeutical validity of multiple drugs prescribed in Leucorrhoea.
• Cost effective therapeutic activity and safety concerned Godanti Bhasma may be considered as drug of choice in Leucorrhoea.

SUMMARY

Shwetapradara is a common disease occurring to many women and form about 10% of cases attending gynaecological clinic. According to Ayurveda vitiated vata and kapha along with dushita rasa dhatu causes dushti of Artavavaha srotas leading to per vaginal white discharge. From the pilot study Godanti Bhasma was considered to be effective in shwetapradara. To assure the quality and to provide scientific clinical data, an attempt was made with this project on “Evaluation of the efficacy of Godanti Bhasma in shweta pradar with special reference of leucorrhoea”.

                       60 patients of Shwetapradara, 20 in each group were taken. Godanti Bhasma with Lukewarm water was administered in Grp I, only lukewarm water in Grp II and Azostat kit in Grp III for 30 days. After 30 days of treatment all the symptoms were relieved in 90-100% of patients in Grp I. 50% of symptoms were relieved in 90-100% of patients in Grp III. Some side effects were noted in Grp III. In Pap smear report, Trichomonous vaganalis, candida albicans and bacterial infection were found negative in Grp I and III patients after treatment, but present in all patients of Grp II. Godanti Bhasma shown significant relief of symptoms than standard drug. Its antimicrobial activity was noted and comparable to that of Azostat kit.

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