Brief  Summary -

After clearance from Ethical Committee of Government Ayurveda College, Nagpur and CTRI Approval, An Open Labelled study will be conducted on 53 Hypertensive Patients as per inclusion and exclusion criteria. They will be recruited from OPD, IPD, Casualty and periphery of Government Ayurveda College, Nagpur.

 During the informed consent process, patients will be given enough time to read and understand informed sheet and consent form. There will be interaction with patient to resolve their queries (if any).  If patient agrees for participation in the study and if found fit to include during screening, then patient will be included in the study.

Our objective for this study is to find out if Tagar combined with Raktamokshana (Therapeutic bloodletting) and Basti (per rectal administration of Ayurvedic medicine) is effective in reducing blood pressure in duration of 90 days.

1st assessment will be on day zero.  After first assessment, Raktamokshana will be done. On the same day oral administration of Tagar will be started, after that Basti (per rectal administration of ayurvedic medicines) will be started as per Ayurveda based clinical findings. The amount of Raktamokshana, Tagar and Basti will be decided as per Ayurveda based Clinical examination of patient. Stages of Doshas and symptoms of patient.

For Anuvasan Basti (per rectal oil administration) Triphaladi Tail will be used; while Panchbhadra Kwath will be used for Niruh Basti (per rectal administration of herbal decoction).

Duration of study – 90 days.

Time of administration –

●        Triphaladi Tail Anuvasan Basti will be administered after meal within a 1 hour.

●        Panchbhadra Kwath Niruh Basti will be administered empty stomach.

●        Tagar will be administered orally in morning after meal and at night after meal.

Determinant of Dose-

1.       Dose of Medicine will be finalized for each patient.

2.       Range of dose for particular medicines are given in the table.

3.       Dose of Basti will vary according to the time at which Basti come out (Basti Pratyagama) and clinical assessment of patients (Aatur Pariksha).

Treatment details- Table no -1

Assessment of scale and physical character will be carried out on zero and 90 th day.

Blood pressure will be measured on daily basis when patient will come for Basti. When patient will not be on Basti Karma blood pressure will be measured once a week.

Patients and investigator’s global evaluations for overall improvement will be done at the end of the study. Tolerability of the trial medicine will be assessed by the investigator and patient at the end of the study. All the patient will be closely monitored for any adverse events/ adverse drug reaction. All the investigations performed on day zero will be repeated on day 90.

Based on the above study procedures, observations will be recorded in the case record forms for each patient.

Following scale will also be used in study along with blood pressure measurements.

1-       Estimated Risk of Developing CHD in 10 Years. (Day zero and Day 90)

2-       Estimated Risk of Developing Hypertension in the next 4 Years. (Day zero and Day 90).

Following investigations included in our study-

Investigation – Table no. 2

Any other investigation which investigators feels necessary at the time of recruitment considering clinical status.