ArticleBMC complementary medicine and therapies2025
Efficacy and safety of ayurvedic intervention (Sarpgandha Mishran) vs amlodipine for Stage-I primary hypertension- study protocol for a prospective Double-Dummy, Double-Blind, placebo-controlled Randomized Clinical Trial.
Article in BMC complementary medicine and therapies, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Review
- Correction: Efficacy and safety of ayurvedic intervention (Sarpgandha Mishran) vs. amlodipine for stage‑i primary hypertension‑ study protocol for a prospective double‑dummy, double‑blind, placebo‑controlled randomized clinical trial.BMC complementary medicine and therapies · 2025Article
Corrections and comments
- Erratum issued
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHypertension presents as a modifiable risk factor for cardiovascular diseases, with approximately two-thirds of the global hypertensive population concentrated in low- and middle-income nations. Sarpagandha Mishran is an Ayurveda intervention utilized for the management of hypertension. The objective of the study is to assess the clinical efficacy and safety of Sarpgandha Mishran in the Management of Stage-I Hypertension.
methodsThis clinical trial employs a prospective design characterized by a double-dummy, double-blind, placebo-controlled methodology being conducted at Cardiology Outpatient Department of the AIIMS, New Delhi. A total of 150 participants (75 per group), diagnosed with Stage-I essential hypertension will be randomized and allocated in a 1:1 allocation ratio, to either Ayurveda group or Conventional Care group. Participants in Group I will receive Ayurvedic intervention, Sarpagandha Mishran 500 mg capsules orally twice daily, in addition to a matching placebo of Amlodipine 5 mg capsules orally once daily. Group II will receive a matching placebo of Sarpagandha Mishran 500 mg capsules along with Amlodipine 5 mg capsules orally once daily. All participants will also be administered Hydrochlorothiazide 12.5 mg tablets orally once daily for a duration of 12 weeks. The primary endpoint of this study involves evaluating changes in SBP and DBP from baseline to week 12. Secondary outcome includes assessing changes in IL-6, Serum Pro-BNP, oxidative stress markers, lipid profile, and the SF-36 Health Survey Score. Safety assessments will be done through recording of AE/ADR and assessments of liver function tests and renal function tests parameters. DISCUSSION: The present study is poised to furnish comprehensive insights into the clinical efficacy and safety profile of Sarpagandha Mishran in the management of Grade 1 hypertension. By adopting a rigorous scientific methodology, this investigation aims to contribute robust evidence that may significantly impact the formulation of future guidelines for integrative treatment protocols in hypertension management.
trial registrationThe trial is prospectively registered with the Clinical Trial Registry of India [CTRI/2021/12/038589], dated 13.12.2021.
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