Startseite Evaluation of the add on effect of Majoone Sarkhas with levothyroxine in primary hypothyroidism: a randomized standard control adjuvant clinical study
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Evaluation of the add on effect of Majoone Sarkhas with levothyroxine in primary hypothyroidism: a randomized standard control adjuvant clinical study

  • Md Anzar Alam EMAIL logo , Mohd Aleemuddin Quamri , Ghulamuddin Sofi und Nafis Haider
Veröffentlicht/Copyright: 21. Februar 2025
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Drug Metabolism and Personalized Therapy
Aus der Zeitschrift Drug Metabolism and Personalized Therapy Band 40 Heft 2

Abstract

Objectives

Primary hypothyroidism is a prevalent endocrine disorder, typically treated with levothyroxine (LT). However, prolonged use of LT may result in complications and suboptimal outcomes for some patients. Majoone Sarkhas (MS), is a polyherbal formulation comprises four plants: Commiphora mukul, Operculina turpethum, Embelia tseriam-cottam, and Dryopteris filix-mas. It is traditionally used in Unani medicine for managing hypothyroidism associated conditions. The aim of this study was to assess the synergistic effect of Majoone Sarkhas in combination with LT for the treatment of primary hypothyroidism.

Methods

This randomized, single blind, standard clinical trial involved 100 subjects allocated into two groups: an adjuvant treatment group (n=50) and a standard control group (n=50). The adjuvant group received 10 g of MS twice daily in addition LT once daily, while the control group was treated with LT alone once daily. Both groups underwent treatment for 60 days. Changes in thyroid-stimulating hormone (TSH), free tri-iodothyronine (FT3), and free-thyroxine (FT4) levels from baseline to the 60th day were recorded and analyzed statistically to evaluate the outcomes.

Results

The study showed adjuvant group (MS + LT) had more reduction (4.99 vs. 3.93) in serum TSH level in comparison to control group (LT), which was statistically significant (p<0.001), it also showed increase in serum FT3 (2.88 ± 0.31 vs. 2.97 ± 0.44) and FT4 (1.06 ± 0.17 vs. 1.20 ± 0.27) levels, when compared with baseline values and after completion of trial.

Conclusions

The change in thyroid function profiles among adjuvant group, receiving MS with LT in primary hypothyroidism was both clinically and statistically significant. The safety parameters those were followed by serum level of ALT, AST, blood urea and serum creatinine were within the range, indicating the MS is safe medication to be used as an adjuvant therapy with LT (Clinical Trial Registration Code: CTRI/2018/02/011962).

Keywords: primary hypothyroidism; polyherbal unani formulation; Majoone Sarkhas ; unani medicine; levothyroxine
Corresponding author: Md Anzar Alam, MD, PhD (Medicine), Department of Medicine (Moalajat), National Institute of Unani Medicine, Bangalore, India; and Department of Medicine (Moalajat), School of Unani Medical Education and Research (SUMER), Jamia Hamdard, New Delhi, 110062, India, E-mail:

Acknowledgments

This study was a part of the fulfilment of the PhD thesis which was supported by the National Institute of Unani Medicine (NIUM), Bangalore (Ministry of AYUSH Government of India). Work is duly acknowledged to our teachers, for valuable suggestions and support throughout the study and especially to the human subjects who were recruited for the study. I am also thanks to Dr. K. P. Suresh, Scientist (Biostatistics), National Institute of Veterinary Epidemiology and Disease Informatics (NIVEDI), Bangalore, for data analysis.

  1. Research ethics: The study protocol was approved by the Institutional Ethics Committee of NIUM (NIUM/IEC/2016-17/032/Ph.D./Moal./01), and the trial was registered with the Clinical Trial Registry of India (CTRI/2018/02/011962).The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013).

  2. Informed consent: Informed consent was obtained from all individuals included in this study.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: Not applicable.

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Received: 2024-12-09
Accepted: 2025-01-06
Published Online: 2025-02-21

© 2025 Walter de Gruyter GmbH, Berlin/Boston

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Clinical pharmacogenomics guidelines: recommendations in different countries and health care systems
  4. Reviews
  5. Genetic variants in NUDT15 gene their clinical implications in cancer therapy
  6. Navigating the crossroads of cell death interplay and intersections among ferroptosis, apoptosis and autophagy
  7. Original Articles
  8. Systems pharmacology of phytochemical anacardic acid in the chemoprevention of hepatocellular carcinoma
  9. Evaluation of the add on effect of Majoone Sarkhas with levothyroxine in primary hypothyroidism: a randomized standard control adjuvant clinical study
  10. Immunomodulatory potential of phosphorus: insights from experimental mice models under normal and immunosuppressive condition
  11. Corrigendum
  12. Acute and sub-chronic oral GLP toxicity of Withania somnifera root extract in Sprague Dawley rats
https://doi.org/10.1515/dmpt-2024-0096
Schlagwörter für diesen Artikel
primary hypothyroidism; polyherbal unani formulation; Majoone Sarkhas; unani medicine; levothyroxine

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Clinical pharmacogenomics guidelines: recommendations in different countries and health care systems
  4. Reviews
  5. Genetic variants in NUDT15 gene their clinical implications in cancer therapy
  6. Navigating the crossroads of cell death interplay and intersections among ferroptosis, apoptosis and autophagy
  7. Original Articles
  8. Systems pharmacology of phytochemical anacardic acid in the chemoprevention of hepatocellular carcinoma
  9. Evaluation of the add on effect of Majoone Sarkhas with levothyroxine in primary hypothyroidism: a randomized standard control adjuvant clinical study
  10. Immunomodulatory potential of phosphorus: insights from experimental mice models under normal and immunosuppressive condition
  11. Corrigendum
  12. Acute and sub-chronic oral GLP toxicity of Withania somnifera root extract in Sprague Dawley rats
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