| CTRI Number |
CTRI/2024/03/064352 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda Intervention in Left Ventricular hypertrophy |
|
Scientific Title of Study
|
Randomized controlled trial of Anshumati Ksheer Paka in hypertension induced left ventricular hypertrophy. |
| 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 Neha Dubey |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
entral Council for Research in Ayurvedic Sciences |
| Address |
Room no 119-B, Ayurveda Section 61-65, Institutional area, opposite D block, janakpuri, New Delhi,
PIN 110058
South West
DELHI
110058
India |
| Phone |
09678867770 |
| Fax |
|
| Email |
ayuneha312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Gupta |
| Designation |
Assistant Professor (Cardiology) |
| Affiliation |
VMMC and Safdarjung Hospital , New Delhi |
| Address |
Room No. 738, Department of Cardiology, Superspeciality Block, VMMC and Safdarjung Hospital , New Delhi
South
DELHI
110029
India |
| Phone |
01126766401 |
| Fax |
|
| Email |
pg.ucms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Dubey |
| Designation |
Research Officer (Ayurveda) |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Room no 119 B, Ayurveda Section, 61-65, Institutional area, opposite D block, janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
09678867770 |
| Fax |
|
| Email |
ayuneha312@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council For Research In Ayurvedic Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council For Research In Ayurvedic Sciences, New Delhi |
| Address |
61-65, Institutional Area, D block, Janakpuri, New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 Puneet Gupta |
VMMC and Safdarjung Hospital |
Room No. 738, Department of Cardiology, Superspeciality Block, New Delhi- 110029 Ansari Nagar East, Near to AIIMS Metro Station, New Delhi
South
DELHI |
01126766401
pg.ucms@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional ethics Committee,Vardhman Mahavir Medical college & Safdarjung Hospital New Delhi |
Approved |
| Institutional ethics Committee,Vardhman Mahavir Medical college & Safdarjung Hospital New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I422||Other hypertrophic cardiomyopathy. Ayurveda Condition: HRUDROGAH, (2) ICD-10 Condition:I517||Cardiomegaly. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Anshumati Ksheerpaka (Desmodium gangeticum medicated milk preparation), Reference: • Anshumati/Shalparni (Desmodium gangeticum): API, Part-I, Vol-VI • Anshumati Ksheerpaka : • Charak Samhita, Vata-vyadhi Chikitsa 28/96, Route: Oral, Dosage Form: Ksheerpaka, Dose: 80(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard Care (Anti hypertensive therapy) | Anti hypertensive therapy dtails:
medications are Angiotensin-converting enzyme inhibitors (ACE inhibitors), Angiotensin II receptor blockers (ARB’s), Beta blockers, Calcium channel Blockers (CCB) and diuretics
Dose and frequency: As per individual Patient requirement
Route of administration: Oral
Duration of Therapy: 6 months
F |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
2. Participants diagnosed with LVH having left ventricular mass index more than 115 g/m2 in men, and more than 95 g/m2 in women, as evidenced by echocardiography.
3. Participants having mild to moderate Hypertension (grade 1 and 2)
4. Participant willing and able to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Left Ventricular Ejection Fraction less than 45% on screening echocardiography.
2. History of myocardial infarction or stroke within 6 months
3. History of Heart failure, ischemic heart disease, valvular heart disease, arrhythmias, peripheral vascular disease, history of any type of cardiac surgery.
4. Renal dysfunction, chronic kidney disease (GFR less than 60 ml/min), Significant chronic renal impairment (Serum creatinine more than 2.0 mg/dL).
5. Severe hypertension (Systolic BP more than or equal to 180 mm Hg or Diastolic BP more than or equal to 110 mm Hg).
6. Diabetic patients with HbA1c more than 7%.
7. Diagnosed Patients of Dyslipidemia having values of total Cholesterol (more than 240 mg/dl), Low Density Lipoprotein (LDL more than 160 mg/dl), Triglycerides (more than 200 mg/dl) and High Density Lipoprotein (HDL less than 40 mg/dl)
8. Known cases of lactose intolerance.
9. Participants who have participated in any other clinical trial within the previous 30 days.
10. Pregnant/lactating females
11. Participants with a history of substance abuse or alcohol abuse and smokers
12. Any other condition which the P.I. thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Left Ventricular Mass Index from baseline |
Baseline, 3 months, 6 months |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Number of participants with reduction of left ventricular hypertrophy
2. Changes in Left Ventricular Ejection Fraction
3. Changes in Left Ventricular end systolic/Diastolic volume
4. Changes in Inflammatory (CRP, IL-6) & cardiovascular blood markers (NT-proBNP, Troponin T)150
5. Number of participants with Adverse Event
6. Safety profile (CBC, LFT, KFT, e-GFR) assessment
|
Baseline, 3 months, 6 months
|
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Prevalence of LVH increases with severity of hypertensive disease. Approximately one third to half of hypertensive patients have LVH. The prevalence of LVH ranges from 5% in patients undergoing angiography to as much as 44% in patients with hypertension. Anti hypertensive drugs such as angiotensin-converting enzyme inhibitors, ARB’s , β-blockers etc. are effective in attenuating the LVH and heart failure. However, in recent years, researchers have shown considerable interest in treating diseases with medicinal plants because of their low toxicity and potential pharmacological properties. Medicinal plants have been used in the Indian system of medicine to treat various diseases, including infectious and non-infectious ones. Desmodiumgangeticum (Fabaceae family) is a small medicinal shrub abundantly found in tropical countries such as India, China, Africa, and Australia (Kurian et al., 2010). The root portion of this plant is used as the main ingredient in famous ayurvedic preparations such as “Dashmoola. This medicinal herb is used to treat various ailments such as digestive, inflammatory, and cardiovascular disorders. Moreover, invitro studies have shown that DG root extracts possess strong antioxidant, anti-hypertrophic, and anti-inflammatory activities (Sankar et al., 2013). Hence, the present study was designed to investigate the efficacy and safety of “AnshumatiKsheerPaka†in Hypertension induced Left Ventricular hypertrophy, as add on therapy to Standard care.
|