| CTRI Number |
CTRI/2025/03/081967 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of High Blood Pressure with purgation therapy by using Aragwadhadi Avaleha |
|
Scientific Title of Study
|
Clinical Evaluation of Virechan Karma of Aragwadhadi Avaleha in the Management of Hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bidushi Mishra |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth College Of Ayurved Pune |
| Address |
OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus
Pune MAHARASHTRA 411043 India |
| Phone |
9827430093 |
| Fax |
|
| Email |
bidushi.mishra-ayurved@bvp.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
Professor and Head of Department Panchakarma |
| Affiliation |
Bharati Vidyapeeth College Of Ayurved Pune |
| Address |
OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus
Pune MAHARASHTRA 411043 India |
| Phone |
9822249807 |
| Fax |
|
| Email |
santosh.chavan@bharatividyapeeth.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Santosh E Chavan |
| Designation |
Professor and Head of Department Panchakarma |
| Affiliation |
Bharati Vidyapeeth College Of Ayurved Pune |
| Address |
OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus
MAHARASHTRA 411043 India |
| Phone |
9822249807 |
| Fax |
|
| Email |
santosh.chavan@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University)College of Ayurved and Hospital,Department of Panchakarma Katraj Pune Maharashtra India 411046 |
|
|
Primary Sponsor
|
| Name |
Dr Bidushi Mishra |
| Address |
Bharati Vidyapeeth(Deemed to be)University,Bharati Ayurved Hospital,Department Of Panchakarma OPD No 21,Dhankwadi,Katraj,Pune |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bidushi Mishra |
College of Ayurveda Bharati Vidyapeeth |
OPD number 21 Ground floor Department of Panchakarma College of Ayurved Bharati Vidyapeeth Pune Satara Road Dhankwadi Campus Pune MAHARASHTRA |
9827430093
bidushi.mishra-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE(BV(DU)COA-EC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: AVRUTA-VATAH/AVARANAVATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak Siddhi Sthan, Procedure details: -Deepan & Pachan- Deepan and Pachan will be given to patient with Takra or Hingwashtak Churna for 3-5 days twice a day before meals.
-Snehan- Abhyantar Snehapan by consumption of Cow`s Ghee for 3/5/7 days till Samyak Snigdha Lakshana are seen.Patient advised to take 3days Vishram for internal consumption of Cow’s Ghee
-Bahya Snehan will be done on Sneha Viram Din by application of Tila Tail will be done after Samyaka Snigdha Lakshana are seen.
-Swedana- Sarvanga Bashpa Peti Swedana will be done starting from Sneha Vishram Din till Virechan Karma day.
-Patient will be advised to take Ushna,Drava,Amla Rasatmak Aahara,Mansarasa,Rice etc during Snehapan and previous day to Virechan procedure.
-Purvakarma will be done after kostha parikshan.
-PRADHANA KARMA:
-Between 8-9.30 am administration of Virechak Yog according to Mridu, Madhyam and
Krura Kostha.
-Patient will be observed for Virechan Vegas (Episodes of induced purgation) to be observed and recorded.
-Patient will be observed for Samyak Vegas and Upavegas.
-Kaphant Virechan Vega will be observed.
) (1) Medicine Name: Aragwadhadi Avaleha, Reference: Charak Kalpa Sthan, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 90(g), Frequency: od, Duration: 1 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients diagnosed with Hypertension.
2.Newly diagnosed patients having six month duration of stage 1 Essential Hypertension SBP(150-160mmHg)or DBP(90-100mmHg)of either sex between the age group of 18 to 60 years were include in this Research project. |
|
| ExclusionCriteria |
| Details |
1.Patient having Stage 2 Hypertension with SBP(Greater than 180mmHg)or DBP(Greater than 110 mmHg).
2.Patient having Stage 1 Essential Hypertensionwith less than six months of durations.
3.Patients contraindicated for Virechan that are Bleeding hemorrhoids,chronic fissure in ano and irritable bowel syndrome. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Lipid profile level. |
Base Line 30th day,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Hypertension |
Base Line 30th day,60th day |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
17/04/2026 |
| Date of First Enrollment (Global) |
01/04/2025 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According
to World Health Organization (WHO), India is going to have most of the
lifestyle disorders in the near future.It is
estimated that 600 million people are affected worldwide with Hypertension.
Hypertension results from a variety of reasons like stress, obesity, genetic
factors, over use of the salts in the diet and ageing.It is a chronic non
communicable disease in which the pressure exerted by the blood on the wall of
the artery is elevated.It is defined as a persistent elevation of systolic
Blood Pressure above 140 mmHg and diastolic pressure above 90mmHg.In Ayurveda Charak clearly describes that
vyana vayu,a component of vata dosha is said to be responsible for various
kinds of movement in the body.With the help of vyana vayu,heart contracts and propels
blood continuously all over body so it suggests the involvement of vyana vayu
in regulation of blood pressure.In modern medicine lots of drugs are available
for controlling blood pressure but they have some side effect, Hence people are
looking towords ayurvedic treatment.
Previously Hypertention
is studied in various ways. From those study we can state that Virechan karma can be found impressively effective in
the treatment of Hypertention. Aragwadha is the drug of choice as a Mrudu
Virechak that is not only beneficial for adults but is safe even for children.It
act as Madhura,Tikta,Katu
Kashaya Rasa having Tridoshashamaka properties which helps in reducing
hypertension by removing Margavarodha and daily elimination of excess morbid
toxic materials from the body through Adhobhaga by the predominance of Jala and
Prithvi Mahabhutas.Thereby it helps in pacifying kapha and pitta Doshas and
simultaneously having its effect on Rakta and regulates the activity and
movement of Vata Dosha by its anulomana action.Virechana helps to decrease the
fluid volume which reduces the cardiac output,subsequently corrects the
Rasa,Rakta Samvahana and helps to reduce the Hypertension.
|