Introduction

Ayurveda has been practiced in India since thousands of years. In this era of industrialization and life-threatening competition the life style of mankind has been drastically changed. The incidence of the disease is increasing day by day due to change in life style and eating habits. Kamala is described in ancient Ayurvedic Granthas like Charaka Samhita, Sushruta Samhita, Madhav Nidana, etc. in the context of Panduroga.  Kamala is named as “Harima” in Atharvaveda. Ayurveda referred Kamala as Paitik Nanatmaja Vyadhi. Shakhashrita Kamala is mainly due to avarodhajanya samprapti in which avarodha may due to Vaata dosha and Kapha dosha. Koshthashakhashrita Kamala is mainly due to dushti of pitta dosha with dushti of Rakta, Mansa dhatu & Yakruta as mool sthana. In Ayurveda Bahupitta Kamala can be compared with hepatocellular Jaundice because of similarity in signs and symptoms. Jaundice is the hallmark symptom of liver disease and perhaps the most reliable marker of severity. Patients usually report darkening of the urine before they notice scleral icterus. Fatigue is the most common and most characteristic symptom of liver disease. In this study Bhunimbadi Churna which is easily available, cost effective, classical & authentic mentioned in Ashtang Hridaya selected or the study. Objectives: To study the Role of “Bhunimbadi Churna? with Gudambu in the management of Bahupitta Kamala. To study various clinical symptoms of Bahupitta Kamala. To observed the effect of Bhunimbadi churna in Bahupitta Kamala. To observe any possible adverse effect of Bhunimbadi churna if reported during the study. Methods: Total number of 30 patients diagnosed Bahupitta kamala who fulfill the inclusive & exclusive criteria selected by random sampling methods.

MATERIALS & METHODS

Preparation of Drug

Bhunimbadi churna is prepared as per classical preparation of Churna kalpana as per Sharangdhara Samhita.The drug was prepared under my observation. The genuine raw drug/material were bought from reliable Pharmacy and a complete quality control check was done. The prepared medicine was found to be sufficient for the trial group of patients i.e.,30 patient.

METHOD:

• Study design & sample size calculation: -

• Patient will be selected from OPD & IPD of our kayachikitsa department.
• Total number of 30 patients diagnosed Bahupitta kamala who fulfill the inclusive & exclusive criteria selected by random sampling methods.
• Among of all selected written consent taken after giving them information about proposed effect of drug used in research.
• Proper case history taken according to the assessment criteria. Follow up will be taken (0-5-15 days).
• Appropriate statistical tests were applied to the data available & analysed to present result.

Sampling Method:

Total 30 clinically diagnosed patient of Bahupitta kamala were selected according to inclusive criteria with simple random sampling method irrespective of gender, religion, occupation, economy status and marital status.

Patient were treated by Bhunimmadi churna

Criteria for Assessments and Results:

Selection criteria:

Inclusive criteria:

1. Patients representing signs and symptoms of Bahupitta kamala.
2. Patient in age group 16 to 60 yrs.
3. Patient selection was irrespective of sex, religion and socio-economic status will be taken.
4. Patients who are willing for trial & consent for Treatment

Exclusive criteria:

1. 1. Patient with Rudhapatha kamala, Kumbhakamala, Halimaka etc.
   2. Patients belonging to age group below 16 and above 60 years.
   3. Patients with any major illness or kamala associated with other systemic diseases.
   4. Pregnant and lacting women.
   5. Patients hypersensitive to any drug.
   6. Patients having Diabetes mellitus.
   7. Signs of hepatic coma.
   8. Patients who donot agree to give Consent.

Withdrawal Criteria:

1. Patients not giving regular follow up.
2. Any reaction occurs due to trail drug

Informed concent -The subject undergoing this study was informed about the narure and purpose of study and written consent of every patient was taken on especially prepreared case paper.

Effect of therapy according to relief in Symptoms score: Table 5.4.3. shows Relieved score and relief in % in Symptoms of Bahupitta kamala by Bhunimbadi churna.

In Netra pitata symptom of 30 patients of Bahupitta kamala before treatment score was 76 and it comes down to 25 after received treatment. Means relieved by 51. i.e., 67.10 % relief for Netra pitata symptom of Bahupitta kamala by Bhunimbadi churna.

In Mutra Pitata symptom of 69 patients of Bahupitta kamala before treatment score was 26 and it comes down to 43 after received treatment. Means relieved by 61. i.e., 62.31% relief for Mutra Pitata symptom of Bahupitta kamala by Bhunimbadi churna.

In Twak Pitata symptom of 30 patients of Bahupitta kamala before treatment score was 73 and it comes down to 24 after received treatment. Means relieved by 49 i.e., 67.12% relief for Twak Pitata symptom of Bahupitta kamala by Bhunimbadi churna.

In Nakha Pitataa symptom of 30 patients of Bahupitta kamala before treatment score was 62 and it comes down to 24 after received treatment. Means relieved by 38. i.e., 61.29% relief for Nakha Pitataa symptom of Bahupitta kamala by Bhunimbadi churna.

In Mukha pitata symptom of 30 patients of Bahupitta kamala before treatment score was 76 and it comes down to 25 after received treatment. Means relieved by 51 i.e., 67.10% relief for Mukha pitata symptom of Bahupitta kamala by Bhunimbadi churna.

In Mala Pitata symptom of 30 patients of Bahupitta kamala before treatment score was 72 and it comes down to 25 after received treatment. Means relieved by 47 i.e., 65.28.% relief for Mala Pitata symptom of Bahupitta kamala by Bhunimbadi churna.

In Avipak symptom of 30 patients of Bahupitta kamala before treatment score was 76 and it comes down to 25 after received treatment. Means relieved by 50. i.e., 67.10 % relief for Avipak symptom     of Bahu pitta kamala by Bhunimbadi churna.

In Trushna symptom of 30 patients of Bahupitta kamala before treatment score was 56 and it comes down to 21 after received treatment. Means relieved by 34. i.e., 66.07% relief for Trushna symptom of Bahupitta kamala by Bhunimbadi churna.

In Indriya daurbalya symptom of 69 patients of Bahupitta kamala before treatment score was 26 and it comes down to 43 after received treatment. Means relieved by 61. i.e., 62.31% relief for Indriya daurbalya symptom of Bahupitta kamala by Bhunimbadi churna.

Discussion

Plan of the study: In the present study, In the present study, maximum no. of patients i.e., 11 were from the age group 32-38 yrs. Followed by 06 in 18-24 yrs, 07 in 25-31 yrs, 3 in 39-45 yrs, 3 in 46-52 yrs and 0 in 53-60 yrs. After the study it was found that, on the observation it was found that, maximum no. of patients i.e., 18 were having Avipak followed by 07 having vishamagni, 03 having tikshnagni and 2 having samagni. Avipak may be the cause of Bahupitta kamala as Avipak indicates the predominance of agnimandya which is the chief cause of Bahupitta kamala. Koshtha: After the study it was found that, on the observation it was found that, maximum no. of patients i.e., 17 were having Madhya koshtha followed by 06 having krura koshatha, 05 having mrudu koshatha and 02 having sama koshatha. Madhyam koshtha is commonly found in kapha prakruti.

Clinical Observations:

1. Netra pitata – On the 1st day 16 patients, 14 patients, were having grade 3, 2, respectively Netra pitata symptom. Progressively severity of symptom goes in decreasing. As on the last 15th day 00 patients of grade 3 and 3 patients in grade 2 while grade 0 patients were found to be increased i.e., 08 patients and 19 patients in grade 1.
2. Mutra Pitata – On the 1st day 09 patients were found who having grade 3 Mutra Pitata symptom of bahupitta kamala followed by 21 having grade 2, 0 were having grade 1 and 0 patients in grade 0. While on the last 15th day 04 patients were found in grade 0, 26 patients in grade 1 and 0 patients in grade 2. No one in the grade 3
3. Twak Pitata- On the 1st day 13 patients were found who having grade 3 Twak Pitata symptom of Bahupitta kamala followed by 17 having grade 2, 00 were having grade 1 and 00 in grade 0. While on the last 15th day 07 patients were found in grade 0 and 22 in grade 1. 1 patient in grade 2 No one in the grade 3.
4. Nakha Pitata - On the 1st day 05 patients were found who having grade 3 Nakha Pitata symptom of Bahupitta kamala followed by 22 having grade 2, 03 were having grade 1 and 00 in grade 0. While on the last 15th day 05 patients were found in grade 0 and 25 in grade 1. No one in the grade 3 and 2.
5. Mukha pitata- On the 1st day 16 patients were found who having grade 3 Mukh pitata symptom of Bahupitta kamala followed by 14 having grade 2, 00 were having grade 1 and 00 in grade 0. While on the last 15th day 07 patients were found in grade 0, 21 in grade 1. and 2. IN grade 2 and No one in the grade 3.
6. Mala pitata - On the 1st day 13 patients were found who having grade 3 Mala pitata symptom of Bahupitta kamala followed by 16 having grade 2, 01 were having grade 1 and 00 in grade 0. While on the last 15th day 06 patients were found in grade 0 and 23 in grade 1 and 1 patient of 2 grade. No one in the grade 3.
7. Avipak - On the 1st day 17 patients were found who having grade 3 Avipak symptom of Bahupitta kamala followed by 12 having grade 2, 01 were having grade 1 and 00 in grade 0. While on the last 15th day 08 patients were found in grade 0 and 19 in grade 1, 03 in grade 2 and No one in the grade 3.
8. Trushna- On the 1st day 01 patients were found who having grade 3 Trushna symptom of Bahupitta kamala followed by 24 having grade 2, 05 were having grade 1 and 00 in grade 0. While on the last 15th day 12 patients were found in grade 0 and 18 in grade 1. 1 in grade 2 No one in the grade 3.
9. Indriya daurablya – On the 1st day 09 patients were found who having grade 3 Indriya daurbalya symptom of bahupitta kamala followed by 21 having grade 2, 0 were having grade 1 and 0 patients in grade 0. While on the last 15th day 04 patients were found in grade 0, 26 patients in grade 1 and 0 patients in grade 2. No one in the grade 3.

10. Total Effect of the Therapy:

11. The total effect of therapy is evaluated by taking relief in percentage of each patient. Out of 30 patients’ good improvement was seen in 04 patients.i.e.,13.33 %. Moderate improvement was seen in 26 patients.i.e. 86.67 %. Mild improvement was seen in 0 patients.i.e. 0.00%. Every patient has got the relief as explained in the above improvement group. Nobody was found in unchanged or no improvement group.
12. As for Netra pitata symptom Bhunimbadi churna shown the 67.10% relief followed by 62.31% for Mutra Pitata, 67.12% for Twak Pitata, 61.29% for Nakh pitata, 67.10% for Mukha pitata, 65.28% for Mala Pitata, 67.10% for Avipak, 66.07% relief for Trushna and 62.31% relief for Indriya daurbalya symptom of all 30 patients of Bahupitta kamala
13. By using Bhunimbadi churna on Bahupitta kamala, symptoms as Netra pitata, Mutra Pitata, Twak Pitata, Nakha Pitata, Mukha pitata, Mala Pitata, Avipak, Trushna and Indira daurbalya were got the 50% to 75 % relief

14. Probable Mode of Action:

    Bhunimbadi churna has Snigdha, Tikshna, Laghu and ruksh Guna and has properties like Agnideepan, Aampachan, Anuloman, Lekhan, Ruchikar, Shothahar etc.By these properties bhunimbadi churna is beneficial for Virechana. It reduces Pittaprakopa as well as reduces signs and symptoms of Bahupitta Kamala and improves digestion. Overall, very good relief found in almost all the patients in present study which is remarkable. It proves that Bhunimbadi Churna with Gudambu is very effective in the management of Bahupitta Kamala.

Conclusion

Without finding some conclusion on any study, it would not become successful in its aims. And a scientific discussion on clinical study definitely gives rise to some fruitful conclusions.

Conclusions drawn from present work are as follows:

1. The total effect of therapy is evaluated by taking relief in percentage of each patient.
2. Out of 30 patients’ good improvement was seen in 04 patients. Moderate improvement was seen in 26 patients. Mild improvement was seen in 0 patient.
3. As for Netra pitata symptom Bhunimbadi churna shown the 67.10% relief followed by 62.31% for Mutra Pitata, 67.12% for Twak Pitata, 61.29% for Nakh pitata, 67.10% for Mukha pitata, 65.28% for Mala Pitata, 67.10% for Avipak, 66.07% relief for Trushna and 62.31% relief for Indriya daurbalya symptom of all 30 patients of Bahupitta kamala.
4. By using Bhunimbadi churna on Bahupitta kamala symptoms as, Netra pitata, Mutra pitata, Twak Pitata, Nakha Pitataa, Mukha pitata, Mala Pitata, Avipak, Trushna, Indriya daurbalya were got the 50% to 75 % relief.
5. The present study was conducted with limited time, limited facilities and limited number of patients. A study of larger group of patients may help to comprehend the mode of action of the trial drug.
6. In the future, additional studies may be performed to take the present issue further in a proper perspective and future possibilities of reduction of modern drug requirement.
7. After treatment we can conclude that Bhunimbadi churna can be used as one of the drugs of choice for better relief in symptoms. Bahupitta kamala is one grievous problem in the world because of which patient is always in trouble. P.G. scholars working on horizon of Ayurveda may have a ray of hope to treat patients of bahupitta kamala give a helping hand to mankind.
8. For further evaluation of this particular drug in case of Bahupitta kamala post graduate scholar of upcoming generation should undertake the project to evaluate Bhunimbadi churna by increasing the dose. It would be worthwhile if the duration of treatment in trial group is increased along with dose. It is in the mind that if drug is administered three times, it will be even more beneficial.