Need for the study 

           Vulvovagintis is a condition with inflammation of vulva and vagina caused due to different microbes, most commonly vaginitis is due to Candida albicans, Trichomonas, and Bacterial vaginosis,¹ where women complain of abnormal vaginal discharge with vaginal itching.²Approximately prevalence rate is 55.6%. White discharge per Vagina is found in 76.3% and White discharge with foul smell is found in 49.6%. ³

            Normal vaginal flora consists of Physiological bacteria’s which provides to prevention against infections, and it maintains the healthy acidic pH. which is anti-microbial.⁴ Changes occurring in pH leads to imbalance of vaginal flora and risk of infections. Acidic medium of the vagina indicates resistance of vagina to external microbes. This condition produces associated symptoms such as pruritus, backache, white discharge with foul smell and alters the pH of the vaginal flora.⁵

This can be correlated to the lakshanas of Kaphaja yonivyapat , The main factors which influence kaphavriddi in day to day life-like indulging in abhishyadhiahara- dadhi,excessive sweet and cold foods, Guda, ghee, milk and milk products, and kaphakara vihara like divaswapna have become almost unavoidable in every woman’s life. This causes Kapha Vriddi and leads to srotodushti causing lakshanas as Picchila, Shwetha yoni srava with Kandu and Alpavedana.⁶

            Management of this condition is by using ruksha, katu  ushna dravyas⁷. Sthanika chikitsa  such as yoni prakshalana(douching), yoni pichu (tamponing), Yoni varti (local use of pessaries)  and yoni dhoopana (fumigation) have been mentioned and theses modalities are found  effective in treating kaphaja yoni vyapat in clinical practise.

            Trivrutadi varti contains trivrut and aragwadha⁸ which have kaphahara, rooksha guna properties, yoni prakshalana with guduchi, triphala  and danti kashaya⁹ which have laghu, ruksha guna, ushna veerya and krimighna  properties and reduces guru, snigdha, sheeta, picchila guna of kapha respectively.
            In another group the yoni prakshalana will be done by using vatalodhra twak kashaya followed by trivrutadi yoni varti.¹⁰
            In 3^rd  group the yoni prakshalana will be done by using sukoshna jala followed by trivrutadi yoni varti.
           In 4^th group the subjects will be administered with Nimbadi guggulu¹¹, as it is Kapha Vata hara, krimighna, kandughna so this drug can be used in kaphaja yonivyapat.
           Thus the study is planned to evaluate the effectivness of nimbadi guggulu and trivrutadi varti with guduchyadi kwatha and vatalodhra kwatha and sukhoshna jala yoni prakshalana  in the management of kaphaja yoni vyapat.

Review of literature

Disease review: 

 Charaka quoted lakshanas of Kaphaja Yoni vyapat are pichhila, sheetala, kandugrastam, alpa-vedanam and panduvarna srava.⁶

    In Sushruta Samhita¹² it is mentioned as three main lakshanas- pichhila, kandu and atisheetala. Madhava, Bhavaprakasha and Yogaratnakar followed the same.

Drug review:

 Yoni dhavana with kwatha prepared of Guduchi, Triphala and Danti cures yoni Kandu.⁹

Use of shyama trivrut and Chaturangula cure kaphaja yoni Vyapat.⁸

Yoni dhavana with Lodhra and vata twak cures yoni srava¹⁰.

As per Bharata Bhaisajya Ratnakara Nimbadi guggulu is kapha-Vatahara, Kandughna, Krimighna and it has antiinflamatory action¹¹.

Previous work done; 

1. Sharon Samuel, A clinical study to evaluate the efficacy of Pippalyadi Yoni Varti in the management of KaphajaYoniVyapata,RGUHS, Bengaluru2013.¹²

In PippalyadiYonivarti, different samples of PippalyadiVarti were prepared by the classical (Bhavana and Gudapaka) and the modified methods (using starch as disintegrating agent).These samples were analyzed using specific parameters and standardized. In vitro assessment of its anti fungal effect against candida albicanswas carried out. Clinical efficacy was assessed by administering PippalyadiYonivarti (prepared by Bhavana method) in 30 patients diagnosed with Vulvovaginal candidiasis. The drug was given for 12 consecutive days in the post menstrual phase and retained overnight. Results were assessed based on relief in signs and symptoms.Only 13% improvement in Sheethasrava and 30% improvement in other YonigataLakshanas like Yoni Kandu, Yoni Daurgandhya and Yoni Vedanawere observed18.

2. P.Chaudhary and Lakshmi Priya, ARCT on efficacy of Nimbadi Yoni Varti on abnormal vaginal discharge in reproductive aged women, JAHM; vol: 2 No 6, 2014.¹³

In NimbadiYonivarti, subjects with abnormal vaginal discharge confirmed by vaginal smear and gram staining (n=100) were selected and grouped as two. NimbadiYonivarti (3grams OD at bedtime for 15 days) as trial drug and Clingen vaginal suppository (1gram OD at bedtime for 7 days) as standard control drug was administered and results were assessed on the basis of relief in signs and symptoms.The p-values for Yoni Kandu was<0.01, Yonisrava and consistency of discharge was <0.02, Yoni Daurgandhya and Yoni Vedana was >0.0519.

3. H.L Kavyashree, Efficacy of Nishadimalahara in the management of sleshmala yoni vyapatw.s.r to Candida albicans, RGUHS, Bengaluru,2015.¹⁴

The effect of nishadimalahara on subjective parameters like picchilasrava was 43.75%, sheetasrava was 43.75%, yoni kandu was 45.36%,yoni vedana was 43.75%; objective parameters showed an improvement 46.15% on quantity of discharge,50%on curdy white flakes and 17% on Candida Albicans all of which were highly significant at p value <0.001.

4. K.L.Sireesha, A clinical study to evaluate the efficacy of Triphaladi Yoni Vartiinthe management of Kaphaja Yoni Vyapata, RGUHS, Bengaluru, 2017.¹⁵

In TriphaladiYonivarti, diagnosed subjects with KaphajaYonivyapt (Vulvovaginitis) (n=36) were selected and TriphaladiYonivarti weighing 3 gms was administered vaginally for 3 hours, twice daily for 7 days and the results were assessed based on relief in signs and symptoms. The analytical study of TriphaladiYonivarti was carried out to trace the standards of Yonivarti17.The effect of Triphaladi Yoni Vartion subjective parameters like PicchilaSravawas 100%, SheetaSravawas 90.9 %, Yoni KanduandYoniVedanawas 60.6%, reduction in quantity of discharge was 78.07 %.20

b.     Research question

  Is Trivrutadi yoni varti and Guduchyadi kwatha yoni prakshalana effective in the management of kaphaja yonivyapat.

Is Trivrutadi yoni varti and Vatalodhra kwatha yoni prakshalana effective in the management of kaphaja yonivyapat.

Is Trivrutadi yoni varti and Sukhoshna jala yoni prakshalana effective in the management of kaphaja yonivyapat.

Is Nimbadi Guggulu is effective in the management of kaphaja yonivyapat.

c.     Objective of the study

To evaluate the effectiveness of Trivrutadi yoni varti and Guduchyadi kashaya yoni prakshalana on microbial flora.(in vitro)

To evaluate the effectiveness of Trivrutadi yoni varti and Vatalodhra kashaya yoni prakshalana on microbial flora. (in vitro)

To evaluate the effectiveness of Trivrutadi yoni varti and Sukhoshna jala yoni prakshalana on microbial flora. (in vitro) To evaluate the effectiveness of Nimbadi guggula in Kaphaja yoni vyapat.(In Vitro)

To study the effectiveness of  Trivrutadi yoni varti and guduchyadi yoni prakshalana in kaphaja yoni vyapat.

To study the effectiveness of  Trivrutadi yoni varti and vatalodhra kashaya yoni prakshalana in kaphaja yoni vyapat.

To evaluate the effectiveness of Trivrutadi yoni varti and Sukhoshna jala yoni prakshalana in Kaphaja yoni vyapat

To evaluate the effectiveness of Nimbadi guggula in Kaphaja yoni vyapat.

To compare the effectiveness in between all the groups

To do literary review of Kaphaja yonivyapat, Vulvovaginitis & all the drugs which will be used in the study.

d. Material and method

i.Source of data

Subjects source- 

The subjects attending the outpatient department and inpatient department of Prasooti Tantra and Stri Roga, Sri Dharmastala Manjunatheshwara College of Ayurveda and Hospital, Hassan and Sri Dharmastala Manjunatheshwara College of Ayurveda, Udupi   will be enrolled in the study. The study will be enrolled after the approval of institutional ethical committee and will be registered in clinical trials registry of India (CTRI)

Drug source-

The raw drugs required for the study will be purchased from the approved vendors and will be authenticated by the department of Dravyaguna, Rasashastra and Bhaisajya Kalpana SDM College of ayurveda Udupi.

ii.Method of collection of data (including sampling procedure, if any)

 A proforma will be prepared with all points of history taking, physical signs and laboratory investigations. The parameters of signs and symptoms will be scored and   will be analyzed by statistical analysis.

Study design-

    It’s an open labelled comparative clinical study.

Sample size-   120 subjects

Group A- 30 subjects

Group B – 30 subjects

Group C – 30 subjects

Group D– 30 subjects

Cochran formula- n₀=z²pq/e²

N₀ -Sample size

Z²- z value found in the Z table at given confidence level

P- estimated proportion of attribute that is present in the population

Q-  (1-p)

E²- desired level of precision

Interventions

Treatment protocol.

Group A- Nimbadi guggulu 2gram thrice a day after food for 2 weeks with Ushna jala as anupana.

Group B, C & D- Subjects will be administered with Trivrutadi varti deep in the vagina for 5 secs followed by yoni prakshalana with above mentioned drugs for 20minutes for 7 consecutive days after the bleeding phase of menstruation.

Criteria for diagnosis:

Abnormal Vaginal discharge associated with itching sensation in the vagina(kandu), with or without low backache (Manda ruja).                    

1.   Inclusion criteria:

  Subjects fulfilling the diagnostic criteria

 Married women of age group between 21-45 years

  Subjects willing to participate in the study and should sign the written consent.

2.     Exclusion criteria:

 Post-menopausal women.

   Pregnancy.

 Cases of HIV, HBsAg, VDRL

Under prolonged use of anti-microbial drugs.

                  â€¢         Women using OCP’s

                  â€¢         Systemic illness like uncontrolled DM & HTN

                  â€¢         Malignancies

iii.Operational definitions/Techniques employed

METHOD OF PREPARATION^{18, 19}

Nimbadi Guggulu will be procured from GMP certified pharmacy.

Trivrutadi varti will be prepared as per Varti Kalpana.

Guduchyadi kwatha and Vatalodhra kwatha will be prepared as per Kwatha Kalpana.

Assessment criteria:

Subjective Parameter

Yoni Srava

Yoni kandu (Itching)

Ruja

 Durgandha 

Objective Parameters:

 Type of discharge (curdy white/yellowish/greenish yellow/white)

 Blood mixed discharge

Vaginal swab

 Vaginal pH 

FOLLOW UP

Total study duration – 7days.

Follow up – on 8th day & 14th day of study

Laboratory Investigations

CBC

RBS

HIV

HbsAg

VDRL

PAP smear

Vaginal PH (BT/AT)

Vaginal swab for culture (BT/AT)

USG abdomen and pelvis.

6.3 List of references

1.     Sunitha, A Clinical Study on Upapluta Yonivyapad w.s.r. to Vulvovaginitis during Pregnancy and its Management with Panchavalkaladi Varti,at Institute for Post Graduate Training and Research in Ayurveda, Gujarat Ayurved University, Jamnagar,2011.

2.     Poonam Choudhary, Further study on Shwetapradara (vaginal discharge) and its management with Nimbadi Yoga, at Institute for Post Graduate Training and ResearchinAyurveda, Gujarat Ayurved University, Jamnagar, 2013.

3.     Priti Singh Verma,   A further study on Upapluta Yoni vyapadw.s.r. to vulvovaginitis during pregnancy and its management with Panchavalkaladi Formulation, Institute for Post Graduate Training and Research in Ayurveda, Gujarat Ayurved University, Jamnagar,2013.

4.     Redondo-Lopez V, Cook RL, Sobel JD. Emerging role of lactobacilli in the control and maintenance of the vaginal bacterial microflora. Reviews of infectious diseases. 1990 Sep 1;12(5):856-72.

5.     Usha V N K ,Streerogavignana 1 st edition delhi, chaulambha Sanskrit prakarshan:2010 p-  585.

6.     Y T Acharya, editor.CarakaSamhita of Agnivesha,Caraka, Drdhabala,ChakrapaniDatta Ayurveda DipikaTeeka,Chikitsasthana;YoniVyapatChikitsa: Chapter 30,Shloka 13. Varanasi: ChaukhambaSurabharathiPrakashana, 2008, p.635.

7.     Y T Acharya, editor.CarakaSamhita of Agnivesha,Caraka, Drdhabala,ChakrapaniDatta Ayurveda DipikaTeeka,Chikitsasthana;YoniVyapatChikitsa: Chapter 30,Shloka 42. Varanasi: ChaukhambaSurabharathiPrakashana, 2008, p.638.

8.     Y T Acharya, editor.CarakaSamhita of Agnivesha,Caraka, Drdhabala,ChakrapaniDatta Ayurveda DipikaTeeka,Chikitsasthana;YoniVyapatChikitsa: Chapter 30,Shloka 62. Varanasi: ChaukhambaSurabharathiPrakashana, 2008, p.640.

9.     Y T Acharya, editor.CarakaSamhita of Agnivesha,Caraka, Drdhabala,ChakrapaniDatta Ayurveda DipikaTeeka,Chikitsasthana;YoniVyapatChikitsa: Chapter 30,Shloka 57. Varanasi: ChaukhambaSurabharathiPrakashana, 2008, p.639.

10.  Y T Acharya, editor.CarakaSamhita of Agnivesha,Caraka, Drdhabala,ChakrapaniDatta Ayurveda DipikaTeeka,Chikitsasthana;YoniVyapatChikitsa: Chapter 30,Shloka 118. Varanasi: ChaukhambaSurabharathiPrakashana, 2008, p.651.

11.  Naginadasa Chaganalal Shah, Gopinath Bhishagratna, Bharata Bhaisajya Ratnakara 3^rd part, 2^ndedition, guggulu prakarana, (3461) Nimbadi guggulu, B. Jain Publishers, Newdelhi, reprint 1999p.189.

12.  Sushruta, Dalhana, Acharya J T. Sushruta Samhita with the nibandha sangraha commentary. 1^st ed. Varanasi. Chaukambha Sanskrit Samsthan; 2010. P105.

13.  Samuel,VBaranwal, Gayathribhat N V.Article on Shodhanivarti in ShleshmalaYonivyapat: A Review,IAMJ: Volume 1; Issue 4; July – Aug 2013.

14.  SamuelSharon.,A clinical study to evaluate the efficacy of Pippalyadi Yoni varti in the management of  Kaphaja Yoni Vyapat.Hassan; 2013.

15.  P.Chaudhary and Lakshmi Priya, ARCT on efficacy of Nimbadi Yoni Varti on abnormal vaginal discharge in reproductive aged women, JAHM; vol: 2 No 6, 2014.

16.  Sireesha K.L., Asokan, V., et.al, Clinical study on efficacy of Triphaladi Yoni Varti in Slaishmiki Yoni Vyapat (Vulvo Vaginal Candidiasis) ; International Journal of Recent Advances in Multidisciplinary Research Vol. 04, Issue 08, p 41-4, August, 2017.

17.  ParmarMeena, Parmar Gaurav. Probable Mode of Action of SthanikaChikitisa (Local Treatment) in Yonivyapada - An Ayurvedic Insight. Int. J. Ayur. Pharma Research. 2014; 2(7): p 25-31. 

18.  Sharangdhara, Sastri P. SharangdharaSamhita. 4th ed. Varanasi. chaukambhaOrientalia; 2000. P196. 

19.  Sharangdhara, Sastri P. SharangdharaSamhita. 4th ed. Varanasi. chaukambhaOrientalia; 2000. P172.