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CTRI Number  CTRI/2023/10/059226 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 16/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effect of Homoeopathic Medicine Gnaphalium in the Treatment of Lowback pain extending to leg 
Scientific Title of Study   A Prospective Clinical Case series Study of Sciatica patients treated with Gnaphalium polycephalum.Q 
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 H Venkatesan  
Designation  Professor and Head 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital Salem 
Address  UG Department of Practice of Medicine, Second Floor, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Venkatesan  
Designation  Professor and Head 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital Salem 
Address  UG Department of Practice of Medicine, Second Floor, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Venkatesan  
Designation  Professor and Head 
Affiliation  Vinayaka Missions Homoeopathic Medical College and Hospital Salem 
Address  UG Department of Practice of Medicine, Second Floor, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO

Salem
TAMIL NADU
636308
India 
Phone  9865134561  
Fax    
Email  venkathompath@gmail.com  
 
Source of Monetary or Material Support  
Vinayaka Missions Homoeopathic Medical College and Hospital Salem  
 
Primary Sponsor  
Name  Vinayaka Missions Homoeopathic Medical College and Hospital 
Address  NH 47, Sankari Main Road, Seeragapadi Post, Slaem, tamilnadu, India 636308 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Venkatesan H  Vinayaka Missions Homoeopathic Medical College and Hospital  Room No 3 D, Dept of Practice of Medicine OPD Unit, Ground Floor, Hospital Block, VMHMCH, NH47, Sankari main Road, Seeragapadi PO
Salem
TAMIL NADU 
9865134561

venkathompath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vinayaka Missions Kirubanandha Variyar Medical College and Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M544||Lumbago with sciatica, (2) ICD-10 Condition: M543||Sciatica,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gnaphalium polycephalum.Q (Mother Tincture)  20 Drops orally with 15 ml of water - Morning and Night for 90 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Sciatica Patients (ICD 11 - ME84.3) 
 
ExclusionCriteria 
Details  Degenerative conditions of spine - Vertebral osteochondrosis, Spondylosis, Facet joints, Spondylolysis & spondylolisthesis, Degenerative stenosis, Known Lesions of sciatic nerve Chronic neuropathic pain by any Specific Diseases
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Scoring tool based on model for clinical assessment items and corresponding predicted probability of sciatica Questionnaire  90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
A modified Roland-Morris disability scale for the assessment of sciatica  90 Days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 4 
Date of First Enrollment (India)   01/11/2023 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Sciatica is a symptom rather than a specific diagnosis. Available evidence from basic science and clinical research indicates that both inflammation and compression are important in order for the nerve root to be symptomatic.1 

            Affected patients experience pain and paresthesias in the sciatic nerve distribution or an associated lumbo-sacral nerve root. Sciatica pain often is worsened with twisting, bending, or coughing. This is often a chronic condition that is managed through the use of analgesics to control the pain and NSAIDs to decrease inflammation. This activity illustrates the evaluation and management of sciatica and reviews the role of the inter-professional team in improving care for patients with this condition.2

            The lifetime incidence of this condition is estimated to be between 13% and 40%. Fortunately, the majority of cases resolve spontaneously with simple analgesia and physiotherapy. However, the condition has the potential to become chronic and intractable, with major socio-economic implications. In about 90% of cases sciatica is caused by a herniated disc with nerve root compression, but lumbar stenoses and (less often) tumours are possible causes. Epidemiological factors found to influence incidence of sciatica included increasing height, age, genetic predisposition, walking, jogging (if a previous history of sciatica), and particular physical occupations, including driving.

            The influence of herniated nucleus pulposus and the probable cytokine-mediated inflammatory response in lumbar and sacral nerve roots is discussed. An abnormal immune response and possible mechanical factors are also proposed as factors that may mediate pain. The diagnosis of sciatica and its management varies considerably within and between countries; for example, the surgery rates for lumbar discectomy vary widely between countries. The ongoing issue of the role of epidural steroid injection in the treatment of this condition is also discussed, as well as potential hazards of this procedure and the direction that future research should take.3,4

 


 

Gnaphalium – General Literature Review:

            The genus Gnaphalium, a herb distributed worldwide, comprises approximately 200 species of the Compositae (Asteraceae) family that belongs to the tribe Gnaphalieae. Some species are traditionally used as wild vegetables and in folk medicine. More than 125 chemical constituents have been isolated from the genus Gnaphalium, including flavonoids, sesquiterpenes, diterpenes, triterpenes, phytosterols, anthraquinones, caffeoylquinic acid derivatives, and other compounds. The extracts of this genus, as well as compounds isolated from it, have been demonstrated to possess multiple pharmacological activities such as antioxidant, antibacterial and antifungal, anti-complement, antitussive and expectorant, insect antifeedant, cytotoxic, anti-inflammatory, antidiabetic and antihypouricemic properties.6 

Gnaphalium – Homoeopathic Literature Review:

            A remedy of unquestioned benefit in sciatica, when pain is associated with numbness of the part affected. Cramps in calves of legs and feet when in bed. Rheumatic pain in ankle joints and legs. Intense pain along the sciatic nerve; numbness alternates with pain. Frequent pains in calves and feet. Anterior crural neuralgia.7 Pains dull or darting or cutting from Right hip-joint posteriorly downward to foot; < lying down, from motion, by stepping, > sitting in a chair.-Intense pain along sciatic nerve.-Numbness occasionally taking the place of sciatic pains, making exercise very fatiguing.-Cramps in calves; in feet, at night in bed.8

Bibliography:

1.    Valat JP, Genevay S, Marty M, Rozenberg S, Koes B. Sciatica. Best Pract Res Clin Rheumatol. 2010 Apr;24(2):241-52. doi: 10.1016/j.berh.2009.11.005. PMID: 20227645.

2.    Davis D, Maini K, Vasudevan A. Sciatica.

3.    https://www.ncbi.nlm.nih.gov/books/NBK507908/

4.    Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. 2007 Jun 23;334(7607):1313-7. doi: 10.1136/bmj.39223.428495.BE. PMID: 17585160; PMCID: PMC1895638.

5.    Stafford MA, Peng P, Hill DA. Sciatica: a review of history, epidemiology, pathogenesis, and the role of epidural steroid injection in management. Br J Anaesth. 2007 Oct;99(4):461-73. doi: 10.1093/bja/aem238. Epub 2007 Aug 17. PMID: 17704089.

6.    Zheng X, Wang W, Piao H, Xu W, Shi H, Zhao C. The genus Gnaphalium L. (Compositae): phytochemical and pharmacological characteristics. Molecules. 2013 Jul 15;18(7):8298-318. doi: 10.3390/molecules18078298.

7.    Boericke W. Materia medica with repertory. InMateria medica with repertory 1927 (pp. 1049-1049).

8.      Clarke JH. A dictionary of pratical materia medica. homoeopathic publishing Company; 1902.

 
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