| CTRI Number |
CTRI/2024/05/067985 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Sarpagandha Vati and Haritaki churna in hypertension |
|
Scientific Title of Study
|
Anti hypertensive Efficacy Of Combination Therapy Of Sarpagandha Vati With Anuloman Chikitsa(Haritaki Churna) On Vyana Bala Vaishamya(Hypertension) randomised clinical trial |
| 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 Jaynarayan Sharma |
| Designation |
PG Scholar |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar Najafgah South West Delhi 110073 |
| Address |
PG Department Of Roga Nidan Evam Vikriti Vigyan, Ch Brahm Prakash Ayurved Charak Sansthan,Khera Dabar, Najafgarh South West Delhi 110073
South West
DELHI
110073
India |
| Phone |
8700601854 |
| Fax |
|
| Email |
jay15503797sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar Madan Singh |
| Designation |
Associate Professor |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Department Of Roga Nidan Evam Vikriti Vigyan, Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,South West Delhi 110073
South West
DELHI
110073
India |
| Phone |
9899867606 |
| Fax |
|
| Email |
ashokdagar01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar Madan Singh |
| Designation |
Associate Professor |
| Affiliation |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Department Of Roga Nidan Evam Vikriti Vigyan, Ch Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, Najafgarh,South West Delhi 110073
South West
DELHI
110073
India |
| Phone |
9899867606 |
| Fax |
|
| Email |
ashokdagar01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ch Brahm Prakash Ayurved Charak Sansthan,Khera Dabar Najafgarh South West Delhi New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Ch Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar, Najafgarh South West Delhi 110073 |
| Type of Sponsor |
Government medical college |
|
|
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 Jaynarayan sharma |
Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Najafgarh New Delhi |
OPD 17 Department Of Rog Nidan Evam Vikriti Vigyaan Ch Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi
South West
DELHI |
8700601854
jay15503797sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ch Brahm Prakash Ayurved Charak Sansthan (CBPACS) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANA, (2) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha vati, Reference: Ayurveda sara sangrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -(2) Medicine Name: Haritaki churna, Reference: Priyavat sharma, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha vati, Reference: Ayurveda sara sangrah, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient of either sex with age between 18-50 years.
Newly diagnosed stage1 primary hypertensive patients( not on medication) |
|
| ExclusionCriteria |
| Details |
Primary hypertension other than stage1 eg. stage2, Benign hypertension, malignant hypertension, isolated hypertension.
Secondary hypertension.
Stage1, primary hypertension with co morbidities.
Stage1 hypertensive patient on regular medication.
Pregnant woman and lactating mother.
Gestational hypertension. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in symptoms of Vyana Bala Vaishamya(Hypertension).
Reduction in blood pressure readings. |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study will provide cost effective
safe drug with lesser side effects. |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="83" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/06/2024 |
| Date of Study Completion (India) |
07/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Vyana Bala Vaishamya cab be defined as imbalance in activities of Vyana Vata which leads to increase in force in the walls of blood vessels. Blood pressure is defined as lateral pressure of column of blood on the wall of blood vessels while flowing through it. Blood pressure affected by two factors i e peripheral resistance and cardiac output. Criteria for normal blood pressure , prehypertension and hypertension (stage1 and stage2) have been recently revised by AHA/ACC( American college of cardiology and American heart association). According to criteria - normal cut-off values for systolic and diastolic blood pressure are taken <120 and <80mmhg respectively. Arterial blood pressure is considered elevated at SBP of 120-129 and DBP <80mmhg. Stage1 hypertension is SBP 130-139mmhg or DBP of 80-89mmhg. Stage2 hypertension is labelled in case with corresponding values of SBP as >=140mmhg and DBP >=90mmhg. Sarpagandha vati abd haritaki churna is effective to reduce blood pressure and symptoms of vyana bala vaishamya.
The present study is aimed to to find efficacy of sarpagandha vati with anuloman chikitsa on vyana bala vaishamya.
The study type is interventional and study design is randomized clinical trial with sample size of 90
|