A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFECT OF AQUEOUS EXTRACT OF TERMINALIA CHEBULA, A PROPRIETARY CHROMIUM COMPLEX, AND THEIR COMBINATION IN SUBJECTS WITH JOINT DISCOMFORT


Chandrasekhar Nutalapati, Uday Kumar Chiranjeevi, Kishan P V, Kiran Kishore K, Usharani Pingali

Abstract


Objective: To evaluate the analgesic effect of an aqueous extract of Terminalia chebula (TCE), a proprietary chromium complex (PCC), and their
combination in subjects with joint discomfort.
Methods: A total of 100 patients with knee joint discomfort were randomized into five treatment groups - TCE 500 mg BID, TCE 500 mg BID+PCC
400 µg OD, PCC 400 µg OD alone, placebo, and TCE 250 mg BID, for 12 weeks in a double-blinded manner. Assessment of symptoms of knee joint pain
and discomfort was done by modified Western Ontario and McMaster Universities Arthritis Index (mWOMAC) and knee swelling index (KSI); visual
analog scale (VAS) was used for subjective assessment of pain, stiffness, and disability. Statistical analysis was done with GraphPad Prism 6.
Results: Absolute reduction in mWOMAC score in TCE 500 mg (19.82±8.35), TCE 500 mg+PCC 400 µg (13.10±5.69), PCC 400 µg (8.30±3.81), placebo
(2.45±3.07), and TCE 250 mg (10.47±4.43), respectively, at the end of 12 weeks as compared to the baseline values. Absolute reduction in KSI in
TCE 500 mg (28.95±16.82), TCE 500 mg+PCC 400 µg (19.14±9.50), PCC 400 µg (12.7±4.86), placebo (10.03±3.8), and TCE 250 mg (18.24±6.86),
respectively, at the end of 12 weeks as compared to the baseline values (p<0.001). Similar results were seen with VAS assessments for pain, stiffness,
and disability. All the treatments were well tolerated.
Conclusion: TCE and PCC reduce joint discomfort.
Keywords: Terminalia chebula extract, Proprietary chromium complex, Western Ontario and McMaster Universities Arthritis Index.


| PDF |

References


Gerwin N, Hops C, Lucke A. Intra-articular drug delivery in

osteoarthritis. Adv Drug Deliv Rev 2006;58(1):226-42.

Fransen M, Bridgett L, March L, Hoy D, Penserga E, Brooks P.

The epidemiology of osteoarthritis in Asia. Int J Rheum Dis

;14(2):113-21.

Mahajan A, Verma S, Tandon V. Osteoarthritis. J Assoc Physicians

India 2005;53:634-41.

Peat G, McCarney R, Croft P. Knee pain and osteoarthritis in older

adults: A review of community burden and current use of primary

health care. Ann Rheum Dis 2001;60(2):91-7.

Laine L. GI risk and risk factors of NSAIDs. J Cardiovasc Pharmacol

;47 Suppl 1:S60-6.

Larkai EN, Smith JL, Lidsky MD, Graham DY. Gastroduodenal mucosa

and dyspeptic symptoms in arthritic patients during chronic nonsteroidal

anti-inflammatory drug use. Am J Gastroenterol 1987;82(11):1153-8.

Laine L. Gastrointestinal effects of NSAIDs and coxibs. J Pain

Symptom Manage 2003;25 Suppl 2: S32-40.

Surya Prakash DV, Sree Satya N, Avanigadda S, Vangalapati M.

Pharmacological review on Terminalia chebula. Int J Res Pharm

Biomed Sci 2012;3(2):679-83.

Nair V, Singh S, Gupta YK. Anti-arthritic and disease modifying

activity of Terminalia chebula Retz. in experimental models. J Pharm

Pharmacol 2010;62(12):1801-6.

Reddy DB, Reddy TC, Jyotsna G, Sharan S, Priya N, Lakshmipathi V,

et al. Chebulagic acid, a COX-LOX dual inhibitor isolated from the

fruits of Terminalia chebula Retz. induces apoptosis in COLO-205 cell

Asian J Pharm Clin Res, Vol 9, Issue 3, 2016, 264-269

Nutalapati et al.

line. J Ethnopharmacol 2009;124(3):506-12.

Kumar CU, Pokuri VK, Pingali U. Evaluation of the analgesic activity

of standardized aqueous extract of Terminalia chebula in healthy human

participants using hot air pain model. J Clin Diagn Res 2015;9(5):01-04.

Pratibha N, Saxena VS, Amit A, D’Souza P, Bagchi M, Bagchi D. Antiinflammatory

activities

of Aller-7,

a novel polyherbal

formulation

for

allergic

rhinitis. Int J Tissue

React 2004;26(1-2):43-51.

Fleck A, Gupta RC, Goad JT, Lasher MA, Canerdy TD, Kalidindi SR.

Anti-arthritic efficacy and safety of crominex 3

(Trivalent chromium,

Phyllanthus emblica extract, and Shilajit) in moderately arthritic dogs.

J Vet Sci Anim Husbandry 2014;19(4):1-7.

+

Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis.

Ann Rheum Dis 1957;16(4):494-502.

Available from: http://www.copcord.org/images/WOMAC.pdf.

Juang LJ, Sheu SJ. Chemical identification of the sources of commercial

Fructus Chebulae. Phytochem Anal 2005;16(4):246-51.

Seo JB, Jeong JY, Park JY, Jun EM, Lee SI, Choe SS, et al.

Anti-arthritic and analgesic effect of NDI10218, a standardized extract

of Terminalia chebula, on arthritis and pain model. Biomol Ther (Seoul)

;20(1):104-12.

Bag A, Bhattacharyya SK, Chattopadhyay RR. The development of

Terminalia chebula Retz. (Combretaceae) in clinical research. Asian

Pac J Trop Biomed 2013;3(3):244-52.

Muhammad S, Khan BA, Akhtar N, Mahmood T, Rasul A, Hussain I.

The morphology, extractions, chemical constituents and uses of

Terminalia chebula: A review. J Med Plants Res 2012;6(33):4772-5.

Reddy DB, Reddanna P. Chebulagic acid (CA) attenuates LPS-induced

inflammation by suppressing NF-kappaB and MAPK activation

in RAW 264.7 macrophages. Biochem Biophys Res Commun

;381(1):112-7.

Jagetia GC, Rao SK, Baliga MS, S Babu K. The evaluation of nitric

oxide scavenging activity of certain herbal formulations in vitro: A

preliminary study. Phytother Res 2004;18(7):561-5.

Sumantran VN, Kulkarni AA, Harsulkar A, Wele A, Koppikar SJ,

Chandwaskar R, et al. Hyaluronidase and collagenase inhibitory

activities of the herbal formulation Triphala guggulu. J Biosci

;32(4):755-61.

Karmakar S, Kay J, Gravallese EM. Bone damage in rheumatoid

arthritis: Mechanistic insights and approaches to prevention. Rheum

Dis Clin North Am 2010;36(2):385-404.

Sabina EP, Rasool M. Therapeutic efficacy of Indian ayurvedic herbal

formulation triphala on lipid peroxidation, antioxidant status and

inflammatory mediator TNF-α in adjuvant induced arthritic mice. Int J

Biol Chem 2007;1(3):149-55.




About this article

Title

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFECT OF AQUEOUS EXTRACT OF TERMINALIA CHEBULA, A PROPRIETARY CHROMIUM COMPLEX, AND THEIR COMBINATION IN SUBJECTS WITH JOINT DISCOMFORT

Date

01-05-2016

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 9 Issue 3 (May-June) 2016 Page: 264-269

Print ISSN

0974-2441

Online ISSN

2455-3891

Authors & Affiliations

Chandrasekhar Nutalapati
Senior Resident, Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad 500082
India

Uday Kumar Chiranjeevi
Senior Resident, Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad 500082

Kishan P V
Senior Resident, Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad 500082

Kiran Kishore K
Senior Resident, Department of Clinical Pharmacology and Therapeutics, Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad 500082

Usharani Pingali


Article Tools


Email this article (Login required)
Email the author (Login required)

Refbacks

  • There are currently no refbacks.