| CTRI Number |
CTRI/2021/12/038589 [Registered on: 13/12/2021] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| 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
|
Clinical study on Ayurvedic intervention (Sarpgandha Mishran) vs Amlodipine for the management of stage-I Primary Hypertension |
|
Scientific Title of Study
|
Prospective Double blind Randomized controlled clinical study on Ayurvedic intervention (Sarpgandha Mishran) vs Amlodipine for the management of stage-I Primary Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D S Arya |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4028, Department of Pharmacology, AIIMS, Ansari Nagar,
Department of Pharmacology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
011-26494266 |
| Fax |
|
| Email |
dsarya16@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D S Arya |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4028, Department of Pharmacology, AIIMS, Ansari Nagar,
Department of Pharmacology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
011-26494266 |
| Fax |
|
| Email |
dsarya16@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D S Arya |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
4028, Department of Pharmacology, AIIMS, Ansari Nagar,
Department of Pharmacology, AIIMS, New Delhi
South
DELHI
110029
India |
| Phone |
011-26494266 |
| Fax |
|
| Email |
dsarya16@hotmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS- Infrastructure
|
| CCRAS- Funding |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, INSTITUTIONAL AREA, OPPOSITE “D†BLOCK, JANAK PURI, New Delhi 110058 |
| 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 Rajiv Narang |
Department of Cardiology, |
CNC Centre,
All India Institute of Medical Sciences,
Ansari Nagar
South
DELHI |
01126593322
r_narang@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sarpagandha Mishran, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Water), Additional Information: Ref: API – Part III; 1st Ed.; Pg 170(2) Medicine Name: Hydrochlorthiazide (HCT), Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 12.5(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Water), Additional Information: (3) Medicine Name: , Reference: NA, Route: -, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 32(5), Frequency: mg, Bhaishajya Kal: od, Duration: Adhobhakta, anupAna/sahapAna: No, Additional Information: -Water | | 2 | Comparator Arm (Non Ayurveda) | | - | Amlodipine | 1. Hydrochlorthiazide(HCT) 12.5mg, OD, with Water for 3 months.
2. Amlodipine 5mg, OD, with Water for 3 months.
3. Placebo of Sarpagandha Mishran 500 mg BD, with Water for 3 months. |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged 30-65 years
2. Diagnosed patients of stage-I essential hypertension as per 8th report of JNC (140-159 mm of Hg SBP and 90-99 mm of Hg DBP)
3. Willing and able to participate for 3 months
|
|
| ExclusionCriteria |
| Details |
1. Patients who have history of Myocardial Infarction, congestive cardiac failure, Stroke or Arrhythmia in the last 6 months.
2. Secondary hypertension.
3. Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.4 mg/dl),uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Neurological disorders, endocrine disorders, etc.) or known cases of malignancy.
4. Known cases of uncontrolled Diabetes Mellitus.
5. Women who are planning for conception / pregnant or lactating.
6. Patients suffering from Psychosis/depressive illness.
7. H/o hypersensitivity to any of the trial drugs or their ingredients.
8. Patient taking participation in any other clinical trial.
9. Participants who were tested COVID-19 positive (through a positive RT-PCR) in the last 30days.
10. Participants with Post COVID-19 complications or BP fluctuations following disease.
11. Participants who are still on COVID-19 related medical interventions.
12. Any other condition, which the P.I. thinks, may jeopardize the safety of the patients.
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes from baseline measurements of systolic blood pressure and diastolic blood pressure. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Change in IL-6 ,Serum Pro- BNP
• Effect on lipid profile
• Change in the SF-36-Health Survey Score.
• To assess the safety of the Sarpgandha Mishran through recording of any AE/ADR reported by study participants
• Change in LFT and RFT parameters in the study participants from baseline to further follow ups
• Change in the level of oxidative stress markers viz., superoxide dismutase
(SOD), catalase (CAT) and glutathione peroxidase (GPX)
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2021 |
| Date of Study Completion (India) |
Date Missing |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a research study being conducted by Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of AYUSH, Government of India, involving administration of Sarpgandha Mishran) with a view scientifically document the clinical efficacy and safety of the said Ayurvedic formulation that have been in use since long period for the management of the Essential Hypertension (Uccha Raktachapa).
|