| CTRI Number |
CTRI/2025/08/092183 [Registered on: 01/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of regular Ashwagandha and Ashwagandha grown with special natural fertilizer on high blood pressure |
|
Scientific Title of Study
|
A comparative phytochemical and clinical study on Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala in Raktagata-Vata with special reference to Essential Hypertention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
UDESH KUMAR |
| Designation |
PhD SCHOLAR |
| Affiliation |
Institute for Ayurveda Studies and Research, SKAU, Kurukshetra, Haryana |
| Address |
DEPARTMENT OF DRAVYAGUNA,BDM COLLEGE OF AYURVEDA SCIENCE AND HOSPITAL, CHHUCHHAKWAS, JHAJJAR, HARYANA
Jhajjar
HARYANA
124106
India |
| Phone |
9466776689 |
| Fax |
|
| Email |
drudeshyadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANIL SHARMA |
| Designation |
Dean |
| Affiliation |
Faculty of Indian Medical System, SGT University, Gurugram |
| Address |
Dean, Faculty of Indian Medical System, SGT University, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9416085092 |
| Fax |
|
| Email |
anilherbals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANIL SHARMA |
| Designation |
Dean |
| Affiliation |
Faculty of Indian Medical System, SGT University, Gurugram |
| Address |
Dean, Faculty of Indian Medical System, SGT University, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9416085092 |
| Fax |
|
| Email |
anilherbals@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
UDESH KUMAR |
| Address |
DEPARTMENT OF DRAVYAGUNA, BDM COLLEGE OF AYURVEDA SCIENCE AND HOSPITAL, CHHUCHHAKWAS, JHAJJAR,HARYANA 124106 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 UDESH KUMAR |
BDM COLLEGE OF AYURVEDA SCIENCE AND HOSPITAL |
Room No. 54, Kayachikitsa OPD, Department of Kayachikitsa
Jhajjar
HARYANA |
9466776689
drudeshyadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, SHRI KRISHNA AYUSH UNIVERSITY, KURUKSHETRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: ASRUGGATAVATAH/RAKTAGATAVATA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagauri Ashwagandha, Reference: Krishnan Vaidyan KV,and Gopalapillai s, Sahasrayogam, Sujanapriya commentary, By Vidyarambham publishers Alapuzha, 28thEdition, pgno-205; Chakradutt vatavydhi chikitsa 2 2/90 ; Rajnighantu Shatahvaadi varga 112, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushanodak), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala, Reference: Sadhale Nalini (1996). Surapala’s Vrikshayurveda - The science of Plant life by Surapala. Asian Agri-History Foundation, Secunderabad, India, 1:104.; Krishnan Vaidyan KV,and Gopalapillai s, Sahasrayogam, Sujanapriya commentary, By Vidyarambham publishers Alapuzha, 28thEdition, pgno-205; Chakradutt vatavydhi chikitsa 2 2/90 ; Rajnighantu Shatahvaadi varga 112, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Ushanodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with the signs and symptoms of Raktagata-Vata supplemented with that of Essential Hypertension is the main criteria for diagnosis.
2. Patients in the age group 18 years to 60 years.
3. Patients who will be giving written consent after providing complete information about the Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala and making process of Kunapajala.
4. Patient having normal Cholesterol level, Kidney function test and ECG findings |
|
| ExclusionCriteria |
| Details |
1. Patients having abnormal Cholesterol level, Kidney function test and ECG findings.
2. Pregnant females
3. Patient having Secondary Hypertension due to known pathology.
4. Patients having age less than 18 years and more than 60 years
5. Patients who will not provide written consent after providing complete information about the Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala and making process of Kunapajala. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A) Comparative study of both samples of Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using Vrikshayurveda based Kunapajala will reveal whether there is any difference in output of both samples on patients of Raktagata-Vata wsr to Essential Hypertension. |
45 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Study will reveal whether Ashwagandha is very much beneficial in treating Essential hypertension as single herb or not |
45 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
29/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A comparative Phytochemical and Clinical
study on Nagauri Ashwagandha and Nagauri Ashwagandha cultivated using
Vrikshayurveda based Kunapajala in Raktagata-Vata wsr to Essential
Hypertention
Research Project Aim To compare the
effectiveness of two types of Ashwagandha in treating essential hypertension
(high blood pressure) with detailed literary review.
Background
Essential hypertension is a widespread
health problem.
Ashwagandha, a medicinal herb, is commonly
used to treat it, with the Nagauri variety being particularly valued.
Vrikshayurveda is an ancient Indian
practice promoting plant growth and phytoconstituents through specific methods.
Research question
Do Ashwagandha cultivated using
Vrikshayurveda-based Kunapajala differ in their pharmacological and
phytochemical properties compared to conventional cultivation, when used for
treating essential hypertension?
Hypothesis
Null hypothesis: There’s no difference
between the two types of Ashwagandha.
Alternate hypothesis There’s a
significant difference in their characteristics.
Objectives
Primary
Analyze the phytochemical makeup of both
Ashwagandha types.
Conduct a clinical trial to assess their
effectiveness in treating essential hypertension.
Secondary
Authenticate the Ashwagandha samples using
traditional and modern methods.
Monitor any potential reduction in risk
factors during the clinical trial.
Methodology
Randomized controlled Clinical study on 2
groups of 30 patients each of essential hypertension.
Sample analysis
Both types of Ashwagandha will undergo
Organoleptic evaluation
Microscopic and macroscopic analysis
Quantitative and qualitative analysis to
meet Ayurvedic Pharmacopeia of India standards
Phytochemical analysis at a certified
laboratory
Witanolide content testing using LCMS/GCMS
methods
Project will contribute to the knowledge
of Ashwagandha cultivation using Vrikshayurveda methods and their impact on its
medicinal properties for treating essential hypertension. CLINICAL
STUDY:-
Drugs will be prepared in pharmacy of BDM College of Ayurveda Sciences,
Chhuchhakwas, Jhajjar. Voluntary Essential
Hypertension patients with informed consent will be selected for the study. 2
groups will be made. 30 patients will be randomly selected in each group.
Group(A) patients who will take Nagauri Ashwagandha Powder
Group (B) patients
who will take Nagauri Ashwagandha Powder cultivated using Vrikshayurveda based
Kunapajala
Sample Size: 60 (30 in each Group)
Anupan: with Sukhambu jal
Follow
up: patients will be followed up every 15 days
Duration: 45 days
|
Group
|
A
|
B
|
|
Number of patients
|
30
|
30
|
|
Drug
|
Nagauri Ashwagandha
|
Nagauri Ashwagandha cultivated using Vrikshayurveda
based Kunapajala
|
|
Form
|
Powder
|
Powder
|
|
Dose
|
3 gm powder BD
Before meal
|
3 gm powder BD
Before meal
|
|
Anupan
|
Sukhambu (Ushnodak)
|
Sukhambu (Ushnodak)
|
|
Duration
|
45 days
|
45 days
|
PATHOLOGICAL TESTS:-
Routine and planned pathological tests will be done before and at the end
of study (1st day & 45th day). Close Monitoring of Systolic and diastolic blood pressure, Kidney
function test, Cholestrol examination and ECG will be done as required and patients
will be confirmed for Essential
Hypertension. General laboratorial
tests will be done as per need.
Improvement
will be observed in both groups according to ayurvedic text and modern text.
|