Open-Labelled, Randomized, Prospective Controlled Clinical Study To Assess Efficacy and Safety Of Karaj Beej Churna Capsule And Triphala Kwath Yonidhavan In The Management Of Kaphaja Yonivyapad W.S.R. To Vulvo Vaginal Candidiasis

Title of Study

“Open-Labelled, Randomized, Prospective Controlled Clinical Study To

Assess Efficacy and Safety Of Karaj BeejChurna Capsule And TriphalaKwath

YonidhavanIn The Management Of KaphajaYonivyapad W.S.R. To Vulvo

Vaginal Candidiasis”

Summary of Background

Need has always been felt to develop certain Ayurveda based treatment modalities for the management of KaphajaYonivyapada and candidiasis which could be safe, effective, readily available, cost effective without any side effects. In comparison to the therapeutic procedures of different systems of medicine, Ayurveda has a potent approach towards the treatment of Kaphaja Yonivyapada and candidiasis by sthanik chikitsa and internal medications. With these backgrounds an effort is made to evaluate the efficacy of Karanj Beej Churna Capsule And Triphala Kwath Yonidhavan in a series of patients suffering from Kaphaja Yonivyapad and Candidiasis.

 Trial Purpose of study

In comparison to the therapeutic procedures of different systems of medicine, Ayurveda has a potent approach towards the treatment of Kaphaja Yonivyapada and candidiasis by sthanik chikitsa and internal medications. With these backgrounds an effort is made to evaluate the efficacy of Karanj Beej Churna Capsule And Triphala Kwath Yonidhavan in a series of patients suffering from Kaphaja Yonivyapad and Candidiasis.

Aims and Objectives:

Aim:

To assess clinical efficacy of Karanj Beej Churna capsule and Triphala kwath Yonidhavan in the management of Kaphaja Yonivyapad, i. e. Vulvo vaginal candidiasis.

Objectives:

Primary Objectives:

1. To assess the safety and effectiveness of Karanj Beej Churna capsule and Triphala kwath Yonidhavanin female patients suffering from Vulvo vaginal candidiasis.

2. To compare the effects of Karanj Beej Churna capsule and Triphala kwath Yonidhavan with only Triphala kwath Yonidhavan group to ascertain its effect on Kaphaja Yonivyapad (Vulvo vaginal candidiasis)

 Secondary Objectives :

1.      To review the literature of Kaphaja yonivyapad with special reference Vulvo vaginal candidiasis.

2.      To review the literature of Karanj Beej Churna and Triphala kwath

3.      To prepare formulation of Karanj Beej Churna capsule and Triphala kwath to standardize it.

   RESEARCH QUESTION AND RESEARCH HYPOTHESIS

Will Karaj beej churna capsule along with Triphala kwath Yonidhavan will be more effective and safe in comparison with Triphala kwath Yonidhavan in relieving Kaphaja Yonivyapad, i. e. Vulvo vaginal candidiasis in females in the age group 20 – 45 years showing classical symptoms of Kaphaja Yonivyapad?

 Oral intake of Karaj beej churna capsule along with Triphala kwath Yonidhavan will be more efficacious and safe in comparison with Triphala kwath Yonidhavan in management of Kaphaja Yonivyapad i.e. Vulvo vaginal candidiasis.

Null Hypothesis (H0): Karaj beej churna capsule along with Triphala kwath Yonidhavan play no significant role in comparison with Triphala kwath Yonidhavan in management of KaphajaYonivyapad, i. e. Vulvo vaginal candidiasis.

Alternative Hypothesis (H1): Karaj beej churna capsule along with Triphala kwath Yonidhavan play significant role in comparison with Triphala kwath Yonidhavan in management of Kaphaja Yonivyapad, i. e. Vulvo vaginal candidiasis.

 Methodology of clinical study-

Place of study - OPD and IPD of Dept. of Prasutitantra, & Streerog, D. Y. Patil Deemed to be

University, School of Ayurveda, Nerul, Navi Mumbai

Type of study: Interventional study

Study design: A Two Arm, Randomized, Open labelled, Controlled, Prospective Clinical Study

Sampling technique: Purposive Sampling

Sample size: A minimum 100 females coming under the inclusion criteria visiting OPD and IPD of Dept. of Prasutitantra, & Streerog, D. Y. Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai will be selected for study by the purposive sampling method and by randomized allocation, will be divided into two groups.

 Written and Informed Consent– A written informed consent of patients in the language best understood by them will be obtained before any trial related procedures.

Follow up will be taken on every 15 days till 1 month, i. e. Day 01 (week 01), Day 15 (week 04), Day 30 (week 05)

 MATERIALS AND METHODS:

i. Literary source

ii. Pharmacological & Pharmaceutical study

iii. Clinical study methodology

iv. Assessment tools

 i. Literary source:

Literary source for present study will be taken from Scriptures, classical texts of Ayurveda,

Sanskrit dictionaries, previous study done in different Universities, books related to contemporary science, articles published in reputed journals and various media like internet

 ii. Pharmacological & Pharmaceutical study:

Pharmacological Study:

a. The formulation, Triphala Kwath contains three ingredients as, Aamlaki (Embilica

officinalis), Haritaki (Terminalia chebula) and Bibhitak (Terminalia bellirica).

b. Karanja Beej Churna Capsule (Pongamia pinnata)

 Preparation of Triphala Kwath -

According to this reference, Triphala Kwath is prepared. 1-part Triphala bharad + 16 part water = boiled upto 1/8th part Kwath remains. 5

c. Authentication, standardization and validation of these raw materials and finished product i. e. Triphala Kwath and Karanja Beej Churna Capsule will be done in botany department of Mithibai College, Mumbai, ALARSIN Laboratory, Mumbai and D. Y. Patil Deemed to be University School of Biotechnology, Belapur, Navi Mumbai.

Pharmaceutical Study:

The Preparation of Triphala Kwath and Karanja Beeja Churna Capsule will be done as per conventional method of preparation. It will be prepared in In-house Pharmacy of Department of Rasashastra and Bhaishajya-Kalpana, D. Y. Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai.

 Intervention:

Group of Patients:

100 patients of kaphaja Yonivyapad will be randomly categorized into 2 groups, each

comprising of minimum 50 patients.

1. Group-A – Trial Group

 Number of patient- 50

The patients of this group will be given Karanja Beeja Churna Capsule

containing 1gm. of churna orally in the morning before breakfast and night

before the dinner with lukewarm water.

Dose: Karanja Beeja Churna Capsule 1 gm twice a day (For 1 Month)

Kala: Before Food

Anupana: KoshnaJala (quantity as required)

Yonidhavan – Triphala Kwath Yonidhavan is procedure in which vaginal canal,

cervical lip are washed with medicated Triphala kwath for 7 days and will be

repeated after 15 days again.

Duration of Treatment –1 month Internal Medications And Yonidhavan for 7 days

and repeated again for 7 days (after 15 days)

 2) Group-B- Control Group

Number of patient- 50

Intervention: The patients of this group will be given Triphala kwath Yonidhavani for 7 days and will be repeated after 15 days again.

Duration of Treatment – Yonidhavan for 7 days and repeated again for 7 days (after 15 days).

 * If any patient of any group experiences vaginal dryness due to the Yonidhavan procedure, this can be alleviated by using Yoni Pichu with Tila Tail (sesame oil) daily for 3 days, with each session lasting 3 hours, which is known for its hydrating and nourishing properties.

 CRITERIA OF ASSESSMENT –

The results will be assessed with regards to improvement recorded in clinical findings and

laboratory investigations, changes to be observed in signs and symptoms. It will be assessed by

adopting suitable scoring methods and objective signs by using appropriate clinical tools.

 Investigations-

All selected patients will be subjected to routine investigations before (Day 0) and after

completion of treatment duration (Day 84), which include the following:

Blood - Hb%, BSL (R), HIV, VDRL

Urine - Routine and Microscopic examination

Vaginal swab.

USG (Pelvis) SOS

SUBJECTIVE CRITERIA –

Symptoms of KaphajaYonivyapad mentioned in the text or practically observed will be assessed at each follow- up and presence or absence of them will be registered.

Assessment will be continued at each follow-up. The improvement in the patients will been assessed mainly on the basis of relief in the signs and symptoms of the disease.

Scoring will be done depending upon the severity of disease.

• Picchilasrava

• Sheetasrava

• Yoni Kandu

• Yoni Vedana

• Quantity of white discharge

 OBJECTIVE CRITERIA –

·         Appearance of External genitalia

·         Appearance of Vagina

·         Tenderness

·         Discharge

·         Nature

·         Quantity

·         Odor