A Clinical Comparative Study To Evaluate The Efficacy Of Bandhyatavhar Vati And Kumari Tail Uttar Basti in The Managment of Stree Bandhyatav W.S.R Infertility Tubal bloackage

Plan Of Study

Material and Method

1. Conceptual study

2. Clinical study

1. Conceptual study- The available literature on ‘Bandhyattava’ and related

drug shall be collected from different Ayurvedic texts, modern texts, authentic

journals, internet and retrospective studies done in various institutions.

2)Clinical study-

Sample source- All the patients will be registered from the OPD and IPD of Prasuti Tantra and Stree Roga Department of State Ayurvedic College and Hospital, Lucknow UP. In the present study, female patients of age group 24 to 42 years will be registered according to the Inclusion criteria.

Type of study- Randomized comparative parallel open clinical trial.

Sample size- minimum 40 patients will be registered.

Group allocation- total 40 patients will be registered randomly

from OPD &IPD of PTSR deptt. Of SAC lucknow.

Screened female will be randomly divided into two groups

Group A- patients of this group will be given the trial drug Bandhyatavhar vati in dose of 2tab BD (500mg each) given orally daily for 3 Consecutive cycle.

Group B- Patients of this group Will be given the trial drug Bandhyatavhar vati along with Uttar basti with kumari tail (5ml) for 3days after cessation of menses.

Treatment Schedule

All patients will be treated priorly with adhonabhigat snehana and swedana

soon after cessation of menses.

’ Uttar Basti’ will be given for 3 consecutive days, followed by per vaginal pichu insertion for 3- 4 hours daily. The same procedure will be executed in three consecutive cycles ( if needed).

Along with these, all patients will be treated with ‘Bandhyatavhar vati’ therapy daily for 3 consecutive cycles.

Follow up study Clinical assessment will be done after each menstrual cycle during trial. Final assessment will be done after completion of trial of 3 consecutive menstrual cycles. Case will be followed upto 2 menstrual cycles after completion of trial without any medication.

During trial- 2 follow ups

After trial- 2 follow ups

Mode of administration- The trial drug shall be administered orally and locally in the form of vati and

uttar basti respectively.

1. Bandhyatavhar vati-

Dosage : 2 tab of Bandhyatavhar vati (250mg each) after meals.

Anupan : Bandhyatavhar vati will be advised with lukewarm water

Frequency of medication : 2 tab of Bandhyatavhar vati will be given for trial in morning and evening after meals daily for 3 continuous months .

2. Kumari taila -

Dosage : uttar basti from 5ml kumari taila.

Frequency of medication : 5ml of kumari taila uttar basti will be given through intravaginally for 3 consecutive days after clearance of menses for 3 consecutive cycles .

Criteria For Selection Of Patients

Pre assessment criteria: Patient from OPD and IPD of Prasuti Tantra

and Stree Roga Department of State Ayurvedic College, Lucknow will be screened out as per the inclusion criteria.

Diagnostic criteria: Diagnosis will be based on the presence of cardinal symptoms of ‘ Stree Bandhyattava’ as unable to conceive after 1 year of unprotected coitus.

1- Inclusion criteria-

A) Age between 24 to 42 years.

B) Patient coming with primary and secondary infertility

C) Patients coming with unilateral or bilateral tubal blockage.

D) Unknown factor (Idiopathic)

2- Exclusion criteria-

A) Patients coming with history of repeated abortion with Active

TORCH Profile (IgM positive).

B) Patients coming with menstrual disorder like- Menorrhagia,

Menometrorrhagia, Secondary Amenorrhea of more than three

months.

C) Patient suffering with any Systemic/ Acute illness.

D) Patient coming with any Genital organ diseases like- Uterine

fibroid, Genital Prolapse, Endometriosis, Adenomyosis, PID,

Genital tuberculosis, Hydrosalpinx etc.

Investigation

1- Hematological examination like- CBC, FBS, LFT, KFT

2- Hormonal profile (if needed) like- Serum LH/ FSH/TSH/

Prolactin/Estradiol/ Progesterone/ AMH.

3- USG (Uterus and Adnexa)

4- HSG

5- TORCH Profile (if needed)

Assessment Criteria

Assessment will be done on the basis of changes seen in the Subjective and Objective criterias.

1- All the signs and symptoms are graded as 0, 1, 2, 3.

2- The clinical improvement during and after trial will be correlated with previous intensity of sign and symptoms.

Subjective criteria

1- Abnormality in menstrual cycle like interval, duration, amount of bleeding, pain.

2- Other associated symptoms like stress, insomnia.

Objective criteria

1- Conception

2- HSG(Hysterosalpingography)

Clinical assessment of total effect of procedure

Maximum improvement- 75- 100% relief in the symptoms

Moderate improvement- 50- 75% relief in the symptoms

Mild improvement- 25- 50% relief in the symptoms

No improvement- <25% relief in the symptoms.