Tagar,Raktamokshan and Basti in the Management of Essential Hypertension.
- Conditions
- Essential (primary) hypertension, ,
- Registration Number
- CTRI/2022/12/048447
- Lead Sponsor
- Dr Rashmi Jaiswal
- Brief Summary
**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 –**
â— *Triphaladi Tail Anuvasan Basti* will be administered after meal within a 1 hour.
â— *Panchbhadra Kwath Niruh Basti* will be administered empty stomach.
â— *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**
| | | | | |
| --- | --- | --- | --- | --- |
|**Treatment**
**Dose**
**Time of medicine administration**
***Anupana*** **(Substance to take along with or after medicines).**
**Route of administration**
|*Tagar*
50-100 mg/Kg
Route of
Administration- Orally
After Meals
*Jala*
Oral administration
|*Raktamokshana*
Therapeutic bloodletting)
3-9 settings of *Siravedh* in 90 days (10-150 ml per setting)
After Meal
**-----**
Venous blood letting
|*Basti krama-*
*Triphaladi tail Anuvasan Basti*
As per stages of Doshas and symptoms of patient
(60-240 ml)
After Meal once in a day (within 1 hour)
***-----***
Per Rectal Administration.
|*Panchbhadra Kwath Niruh Basti*
As per stages of Doshas and symptoms of patient
(400-960 ml)
Empty stomach once in a day
***-----***
Per Rectal Administration.
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**
| | | |
| --- | --- | --- |
|**PATHOLOGICAL**
**B.T. (On day zero)**
**A.T. (On day 90)**
|CBC
√
√
|LIPID PROFILE
√
√
|LFT
√
√
|KFT
√
√
|BSL (FASTING AND POST MEAL)
√
√
|URINE ROUTINE AND MICROSCOPIC
√
√
|URINE MICROALBUMINURIA AND MACROALBUMINURIA
√
√
| | | | |
| --- | --- | --- | --- |
|**RADIOLOGICAL**
**ELECTROPHYSIOLOGICAL**
**B.T. (On day zero)**
**A.T. (On day 90)**
|2D echo (if necessary)
ECG
√
√
|Chest X ray (if necessary)
|USG abdomen (if necessary)
| | | |
| --- | --- | --- |
|**CLINICAL**
**PARAMETERS**
**B.T. (On day zero)**
**A.T. (On day 90)**
|BLOOD PRESSURE
Blood pressure measurement will be on daily basis.
Blood pressure measurement will be on daily basis.
|Height
√
√
|Weight
√
√
|BMI
√
√
|AbdominalCircumference**.**
√
√
|Hipcircumference
√
√
|W/Hratio
√
√
|Skin fold
A- Shoulder fold
B- Abdominal fold
√
√
|Pulse rate
Measurement will be on daily basis.
Measurement will be on daily basis.
|Respiratory rate
Measurement will be on daily basis.
Measurement will be on daily basis.
|Temperature
Measurement will be on daily basis.
Measurement will be on daily basis.
Any other investigation which investigators feels necessary at the time of recruitment considering clinical status.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 53
- 1.Patients having high normal Blood pressure, Stage I hypertension, Stage II hypertension, isolated systolic and isolated diastolic hypertension.
- 2.Patients having history of hypertension less than 10 years 3.Patients who are willing to participate in trial and ready to give written informed consent.
- 4.Patients in between 18 to 70 years of age.
- 5.Patients having serum.
- creatinine level less than 1.4 mg/dl.
- 6.Patients who have not participated in any research project in last 6 months.
- 1.Patients who are not willing to participates in study and not ready to give written informed consent.
- 2.Patients having age below 18 years and above 70 years.
- 3.Patients having history of hypertension more than 10 years.
- 4.Patients having stage III and above hypertension will be excluded.
- 5.Patients having hypertension other than essential hypertension.
- 6.Patients with uncontrolled diabetes mellitus (Random Blood glucose level >200 mg/dl) 7.Pregnant women and lactating mothers.
- 8.Patients with serum.
- creatinine value more than 1.4 mg/dl.
- 11.Any other patients that physician feel should not include at that point of recruitment considering clinical scenario.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Blood pressure 90 days
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Goverment Ayurved College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Goverment Ayurved College and Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaAmit NakanekarPrincipal investigator9850233016amitnakanekar@gmail.com