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Introduction

White discharge is very common among the females due to this changing life style, about 41% of women in reproductive age group suffer from white discharge. Itching at vagina, mild pain in vagina and katishul is also very common, these may be due to poverty as she can't get proper diet which leads to malnutrition. Improper hygiene and local uncleanliness is also responsible for above symptoms. This all symptoms  come under Kaphaja yonivyapada. Kaphaja yonivyapad is described by many Aacharya Bruhatrayi, Laghutariyas, Nighantus and in other grantha as a condition in which pichil sheetal strava from vagina with kandu and manda ruja along with pandu and arthva dusti. These features can be correlated to vaginal candidiasis which shows pruritis, abnormal vaginal discharge, vaginal irritation and soreness of vagina. For the treatment of vaginal candidiasis broad spectrum antifungal agents along with the topical application of azole drugs are used. Symptoms of kaphaja yonivyapada are major source of discomfort due to uncontrolled vaginal pruritis or vaginal discharge so that it can generate stress and sexual anxiety, nearly 40% of women suffer from white discharge, sometimes patient prefer to undergo hysterectomy before 40 yrs because of extreme white discharge. Now a days vulvo vaginal candidiasis is also very common in women, which shows the symptoms of curdy white discharge and vaginal itching. Vulvo vaginal candidiasis is fungus or yeast infection on the vulva or/and vagina caused by candida albicans being the major culprit. About 90% of this infection is caused by candida albicans and 10% by other Species of candida, about 75% of females experience at least one episode of vaginal candiasis during their life time, prevalence rate of vaginal candidiasis in reproductive age group women is 30-35%. Considering above facts and to give new easily available, affordable treatment options, the topic for dissertation ‘Kaphaja yonivyapada’ was selected. For that in samhita’s many useful ayurvedic drugs is mentioned, one of them in Udumbar tail pichu, it is ayurvedic preparation and has properties to reduce kaphaja yonivyapada. Aacharya Charaka in Chikitsa sthan 30 shlok no.77 has mentioned that Udumbara taila yonipichu should be used for kaphaja yonivyapada.

Udumbara taila-

Considering properties (rasa, guna, virya, vipaka, doshaghanata and rogaghanata, karma) of udumbara taila contents i,e udumabara phala and tila taila which is used to prepare udumbara taila, due to action of drug in kaphaja yonivyapada this study was selected.

AIM AND OBJECTIVES

Aim :

To study the efficacy Of Udumbara Taila Pichu Dharana in the    management of kaphaja yonivyapada.

Objective

• To evaluate  efficacy of udumbar taila.

To review the literature of  kaphaja yonivyapada

MATERIAL AND METHOD

Materials

Literary review:

1. Review of literature was done from classical text, samhitas, granthas, modern literature and web sites.

2. References of kaphaja yonivyapada were collected from Ayurvedic samhitas and about leucorrhea, vaginal candidiasis, differential diagnosis of white discharge was collected from modern text.

Clinical study:-

Ethical Clearance :

Clearance from the Institutional Ethical Committee was obtained.

a. Study design:

A randomized open controlled study in patients diagnosed as Kaphaja yonivyapada was done.

b. Sample Size :

60 patients (30 patient in each group)

c. Selection of patients : For clinical study, 60 patients with complaints of white discharge were randomly selected irrespective of religion, occupation,socio economic conditions equally divided in two groups namely- Trial group/Case group (Group A) and Control group (Group B) with 30 cases in each group.

d. Study population: Married women suffering from white discharge between age group 20-45 yrs

e. Place of work: The study was conducted in IPD and OPD of Prasuti avum streeroga department of govn ayurvedic college and hospital Osmanabad. Total 60 patients were selected randomly.

f. Consent : A consent explaining about the clinical study and a written consent was taken from the patients in the language best understood by them, before their participation in the trial.

Criteria for selection of patients

1. Inclusion criteria-
   1. Age between 20-45 years
   2. Shweta strava
   3. Itching 
   4. Katishula
   5. Mild pain at vuval region
2. Exclusive criteria-

             1. Unmarried Women       

             2. Pregnancy

             3. Patient with major illness (HT, DN, STD, AIDS etc.)

             4. Known case of any malignancy

             5. Anaemia

1. Withdrawal Criteria:
   1. The patient is not willing to continue the treatment or to follow the assessment schedule.

            2. If patients will be migrated to any other place

Investigations:

        CBC, BSL-R, HbsAg, ICTC

        Urine - Routine examination

        USG if required, Papsmear if required

 Gynaecological Examination:

         Per speculum examination

         Pervaginal examination

         Per abdomen

Assessment Final:

For assessment of clinical results, we prepared symptom flow chart by giving gradations to symptoms. The symptoms like gandha could not be graded so we gave these symptoms a subjective type of gradation in present absent manners.

2. OBJECTIVE CRITERIA-

1. Curdy white discharge or watery discharge

2. Red and Swollen vulva with evidence of pruritis like scratch marks.

DRUGS:

1. Udumbar taila - Trial drug

2. V3 tablets - Control drug

1. Trial drug-

Authenticate  raw product of Udumbar and tila was taken to prepare Udumbar taila and standardization was done of final product and used pichudharan for 7 days after 7th day of menses for 3 consecutive cycles.

2. Control drug-

Standard Candid V3 VT (Glenmark) available in the market which was given to the patient for 3 days after 7th day of menses for 3 consecutive months.

Standardization of Drug:

Authentication done of raw material from Sheetal analytical laboratory Pune and prepared according to the standard method given in the charaka samhita and standardization done at the Sheetal analytical laboratory Pune of final Drug.

Methods:

Preparation of drugs:

Udumbar taila - Udumbar taila prepared in college pharmacy according to reference in charaka Samhita Chikitsa sthan 30 adhya.

Discussion

In present study, discussion on observations and result is done to make conclusion. Discussion on “Controlled randomized clinical studies on udumbara taila pichu dharana in kaphaja yonivyapada” is done according to literary review drug, plan of work, observations.

1. Discussion on literary review-

Description about khaphaja yonivyapada is mentioned in Samhitas like  Charaka, Sushruta, Bhela, Kashyapa, Sharangdhara, Ashtang Sangraha, Ashtang Hridaya, Yogratnakara and madhavnidana etc.

Acharya Charaka have mentioned:

In present study, Udumbara taila yoni pichudharana has been selected according to following reference where charaka has described stravahara role of udumbara taila pichurana.

2. Drug discussion-

As drug action depends on rasa, veerya, vipak, guna for its efficacy hence drug having properties which can break Samprapti is used.

Drug used- Udumbar phala, tila taila

Action of Udumbara taila:

Udumbar taila contains udumbar phala and tila taila. Drug action mainly takes by rasa, guna, veerya, vipaka, karma and prabhava. In the same way Udumbara taila acts as kaphagna, kandughna, varnya, shothhara, shulhara for kaphaja yonivyapada. Yonipichu acts on prathamavarta and dwitiyavarta and due to snighdha and ushna guna of tila taila it reduces katishula. When Udumbara taila pichudharana is given, taila gets absorbed as it comes in contact with prathamavarta and dwitiyavarta and action takes place. Kasaya rasa of Udumbara phala causes sthanika sira sankoch which reduces strava in vagina thereby reducing kandu. Due to snehana and its ushna virya guna tila taila which is used to prepare udumbara taila is vedananasthapak, tila taila itself is vatasamaka due to its properties hence Udumbara taila also reduces katishula. Ushna virya of tila taila causes kleda pachana which is responsible for strava and kandu. Ushna virya cause shamana of sheeta guna of kapha. Ruksha guna, katu vipaka causes kapha shaman and lekhana of vitiated kapha.  Finally, we can say that contents present in Udumbara taila  are yonigata shweta pichhila stravahara, kandughna, shophahara, vedanahara, this action was seen in kaphaja yonivyapada.

3. Discussion on plan of work

The patients coming to the hospital were with varied.

Withdrawal Criteria:

  1. The patient is not willing to continue the treatment or to follow the assessment schedule.

  2. If patients will be migrated to any other place.

b. Drug quantity:

Group A - Drug quantity to each patient was decided according to pilot study.

Patients were treated with 10 ml of Udumbara taila yonipichu BD for seven days for 3 consecutive cycles of menses.

Group B - Patients were treated with Candid V3 VT for 3 days at bed time for 3 consecutive cycles after 7 day or stoppage of menses.

. Route of drug administration:

Udumbara taila pichudharan and v3 tablets was administered per vaginally in Stree-roga and Prasutitantra OPD, IPD of college or self by patient at home with taking all aseptic precautions.

d. Formulations:

The contents in Udumbara taila helps in sampraptibhanga thereby reducing yonigata shweta picchil strava, yonikandu, yonishotha, vrana and katishula. Also content in v3 tablets helps reducing symptoms

e. Follow up examination:

Group A- Follow up taken every month for 7 days after stoppage of menses for 3 consecutive cycle which helped in assessment of reduction of symptoms according to gradations.

Group B- taken every month for 3 days after stoppage of menses for 3 consecutive months.

Discussion on observation:

For purpose of clinical trial and control, patients were enrolled according to assessment criteria and detail clinical examination along with per vaginal and per speculum examination, inform consent, lab investigations was done and 60 patients were selected out of them 30 patients were treated with 10 ml BD of Udumbara taila pichudharan per vaginally for seven days and 30 patients were treated with v3 tablet for 3 days at bed time after stoppage of menses for 3 consecutive months.

After  the treatment

1. Yonigata shweta picchil strava-

In group A - Shwetastrava was absent in 19, alpa in 10, madhyam in 1

In group B - Shwetastrava was absent in 22, alpa in 8 and madhyam in 0.

Due to pharmacological action in both drugs strava praman was reduced. As value of p is greater than 0.05, insignificant difference was observed between the mean of difference of group A and group B, hence drug of both group A and B are almost equally effective to reducing strava pramana.

2. Yonikandu - After treatment kandu in group A  it was absent in 21, Alpa in 9 patients and madhyam in 0 patients.

In group B it was absent in 24 patients, mild in 6 patients and moderate in 0 patients.

Conclusion

After completion of the study, it is found that an Ayurvedic Regimen-Udumbara taila yonipichu is effective on reducing symptoms of kaphaja yonivyapada as per Subjective/Objective parameters. Statistical analysis after study showed udumbara taila yonipichu is to be statistically equally effective with control group Candid V3 VT but not exactly equal. Total % of relief : Group A-83.76 %, Group B-83.42%. Hence it is concluded that Group A is not exactly equally effective with group B but it is to be statistically equally effective with Group B but overall Group A shows slightly more percentage of relief without having any side effects.