A Comparative Clinical Study to evaluate the efficacy of Ashwagandha Churna and Madanphaladi Pottali in the management of Garbhashaya Yoni Bhransh wsr to Utero vaginal Prolapse

A.        Conceptual study            B.          Clinical Study

A. CONCEPTUAL STUDY :

The available literatures on related  drugs, Garbhashaya-yoni bhramsha and Utero vaginal prolapse shall be collected from different Ayurvedic text, modern text, reputed journals and retrospective studies done in various institutions.

·            On the analysis of all review literatures, conceptual hypothesis is being made to evaluate the effect of oral administration of Ashwagandha churna and Madanphaladi pottli in the registered patients of garbhashaya- yoni bhramsha w.s.r. to utero-vaginal prolapse.

 B.     CLINICAL STUDY

1.       Sample Source : All the patients will be registered from the OPD and IPD of PG Department of Prasuti Tantra and Stri Roga, State Ayurvedic College and Hospital, Lucknow, UP.

In the present clinical study the patient of age group of  35-60 years will be registered for proposed clinical trial.

2.       Type of Study : Randomized comparative parallel open clinical trial.

3. Sample size : Minimum 40 patients in two groups will be registered.

Group Allocation :

Registered patients will be randomly divided into two groups :

Group-A :  This group of patients both of reproductive age group and menopausal  one will be given the trial drug Ashwagandha churna orally for 3 continuous months & Madanphaladi Pottali locally for 10 consecutive days after clearance of menses in reproductive age grouped patients for 3 continuous cycles and 10 consecutive days every month for menopausal patients for 3 continuous months.

Group-B : The reproductive age group patients of this group will be given the trial drug Madanphaladi Pottali locally for 10 consecutive days after clearance of menses in reproductive age group patients for 3 continuous cycles  and in menopausal patients for 10 consecutive  days every month for 3 continuous months.

TRIAL DRUG/THERAPY

DRUG STANDARDIZATION and SAFETY PROTOCOL :

The raw material for trial drug will be purchased from the authentic Ayurvedic aushadhi bhandar and available raw drugs will be verified for the clinical trial by the Department of Dravyaguna before preparation for clinical trial. The trial drug will be prepared in the pharmacy of State Ayurvedic College, Lucknow by concerned experts and under the supervision of  Department of RasaShashtra & Bhaishajya Kalpana.

MODE OF ADMINISTRATION :

The trial drug shall be administered orally and locally in the form of churna and pottali respectively.

1.Ashwagandha Churna :

 **Dosage :**5 gm of Ashwagandha churna BD.

Anupan : Ashwagandha churna will be advised with lukewarm milk.

Frequency of medication : 5 gm of Ashwagandha churna will be given for trial in morning and evening daily for 3 continuous months in both reproductive age grouped and menopausal patients.

 2. Madanphaladi Pottli :

Dosage : 12 gm Pottali will be kept intravaginally.

Dharana Kal : Patient will be asked to evacuate her bladder before dharana of  Madanphaladi pottali and it will be kept till next urge of urine (approx. 3-4 hours).

Frequency of medication : 12 gm pottaliwill be kept intravaginally for 10consecutive days after clearance of menses in reproductive age grouped patients for 3 continuous cycles and in menopausal patients for 10 continuous days every month for 3 months.

 DURATION OF TRIAL & FOLLOW UP :

Duration of trial : It will be trial of 4 consecutive months. 3 months with clinical therapy and 1 month drug free follow-up.

Follow up during treatment : The trial of local drug will be given for 3 consecutive cycles after clearance of menses in reproductive age grouped patients and  at the interval of 20 days of every month in menopausal patients for 3 continuous months.

 The trial of oral drug will be given regularly for 3 months in both reproductive age grouped patients and menopausal patients.

**Follow up:**Follow up of all the patients will be for 4 months and last month will be drug free.

CRITERIA FOR SELECTION OF PATIENTS :

A. Pre-assessment criteria**:** Patients from Prasuti tantra and Stri roga OPD and IPD will be screened out by the symptoms.

B. Diagnostic Criteria : Diagnosis will be based on the presence of cardinal and associated symptoms of garbhashaya-yoni bharmsha.

Cardinal symptoms -

·             Feeling of something coming down  per vaginum

·            Backache or dragging pain in the pelvic region.

·            Feeling of heaviness in pelvic region

·            Variable discomfort and pain on movement.

·            Pain in change in posture

·            Vaginal discharge

Associated Symptoms –

·            Burning micturition

·            Painful micturition

·            Increased frequency of micturition

·            Constipation

·            Dyspareunia

C.  Gyneacological Examinations :

a.        Inspection of Vulva –

·       Healthy or Unhealthy

·       b.       Per Speculum Examination-

·       Cervical   congestion

·       Vaginal discharges

·       Vaginal wall laxity

·       c.      Per Vaginal Investigation  -

·       Cervical tenderness

·         Uterus size & position

·       d.      Lab Investigations -

·       CBC

·                     Sugar (F/PP)

·          Vaginal pH

·       Urine (Routine and Microscopic).

·           USG, Pap smear (if needed).

D. Inclusion Criteria :

·            Patient willing to participate in the study with proper written consent.

·            Patient ready to abstinence.

·            Patient fulfilling cardinal symptoms of garbhashaya-yoni bharmsha.

·            Patient having cystocele , rectocele , 1°& 2° Uterine prolapse.

·            Multiparous women.

·            Patient aged between 35-60 years.

E. Exclusion Criteria**:**

·       Complete procidentia

·       Patient having vaginal infections.

·       Patient not willing for abstinence.

·            Patient having systemic diseases like HTN, DM, Thyroid disorder with the present study.

·            Pregnant and lactating women.

·            Patients with OCPs and IUCDS.

·            Patient with any pelvic pathology or malignancy of genital organs.

F. Discontinuation Criteria :

·            Patient does not want to continue trial.

·            Patient not willing for abstinence.

·            Aggravation of complaints.

·            Any other acute illness or complications.

 ASSESSMENT CRITERIA :

Assessment will be done on the basis of improvement in the sign and symptom for the purpose

·            Feeling of something coming down per vaginum.

·            Backache or dragging pain in the pelvic region.

·            Feeling of heaviness in pelvic region

·            Pain during movement

·            Pain during change in posture

·            Vaginal discharge

  Â·             Associated Symptoms –

·            Burning micturition

·            Painful micturition

·            Increased frequency of micturition

·            Constipation

·            Dyspareunia

 Gynaecological Examinations**:**

·       a.        Inspection of Vulva –

·       Healthy or Unhealthy

·       b.       Per Speculum Examination-

·       Cervical   congestion

·       Vaginal discharges

·       Vaginal wall laxity

·       c.      Per Vaginal Investigation  -

·       Cervical tenderness

·         Uterus size & position

·       d.      Lab Investigations -

·       CBC

·                     Sugar (F/PP)

·          Vaginal pH

·       Urine (Routine and Microscopic).

·           USG, Pap smear (if needed).

Assessment of total effect of Therapy :

Based on the assessment of the sign and symptoms, the total effect of therapy    is evaluated and grouped according to following criteria –

 Marked improvement**:   75 to 100% relief in the syptoms.**

Moderate improvement**:   50-75% relief in the symptom.**

Mild Improvement**:    25-50% relief in the symptoms.**

Unchanged**:     Less than 25% relief in the symptoms.**

Statistical Analysis :

Appropriate statistical tools will be used for assessment at the end of the trial