| CTRI Number |
CTRI/2024/05/067514 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of foot massage with clove essential oil in individuals with diabetic peripheral neuropathy |
|
Scientific Title of Study
|
The effect of foot massage with Clove Essential Oil on enhancing Vibration Perception Threshold(VPT) in individuals with Diabetic Peripheral Neuropathy - A Randomized controlled trial |
| 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 R Pavithra |
| Designation |
Post- Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8525854005 |
| Fax |
|
| Email |
pavithrabnys@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
7010095804 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr R Pavithra |
| Designation |
Post- Graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8525854005 |
| Fax |
|
| Email |
pavithrabnys@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
|
|
Primary Sponsor
|
| Name |
Dr R Pavithra |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu, Tamil Nadu. |
| Type of Sponsor |
Other [Self] |
|
|
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 R Pavithra |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184/4, International
Institute of Yoga and
Naturopathy Medical
Sciences, Faculty Block
(Ground Floor),
Department of Yoga,
Kamarajar Nagar,
Chengalpattu. Kancheepuram TAMIL NADU |
8525854005
pavithrabnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Foot Massage with Carrier oil (Gingelly oil) |
Foot Massage with Carrier oil (Gingelly oil) for 10 mins in a day for 5 times a week for 4 weeks |
| Intervention |
Foot Massage with Clove Essential oil and Carrier oil (Gingelly oil) |
Foot Massage with Clove Essential oil and Carrier oil (Gingelly oil) for 10 mins in a day for 5 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Previously diagnosed patients with T2DM and DPN 2. Patient who meets the eligible criteria for Peripheral Neuropathy it includes tingling, numbness, burning sensation, pain, muscle weakness, loss of reflexes, or problems with coordination and balance
3. Patient with HbA1C less than 8 percent, Vibration perception threshold (VPT) between 16V to 25V
4. Patient who passed Skin patch test for Clove Essential oil
5. Patient who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patient who having open wound, Diabetic foot Ulcer
2. Patient who Smokes, drinks alcohol, Patient with Autoimmune disease
3. Patient with Stroke/Epilepsy, Patient who are under Medication that may influence Nerve function (example anti epileptic drugs)
4. Patients with Low Back Pain and its radiating to the lower extremity, Women during pregnancy, Lactation and Women planning pregnancy
5. Patient who are allergic to Clove essential oil
6. Patient with Deep vein thrombosis or Bleeding disorders
7. Patient who has done any metal implantation in Lower Extremity |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vibration Perception Threshold test |
baseline and after 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hot and Cold perception test |
baseline and after 4 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
03/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/06/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Diabetes mellitus is a chronic, metabolic disease characterized by elevated blood glucose levels (or blood sugar), which over time causes a serious damage to the heart, blood vessels, eyes, kidneys and nerves. Type 2 diabetes mellitus (T2DM), occurs usually in adults and is a common type, which occurs when there is insulin resistance or when the body fails to produce sufficient insulin. In the past 3 decades the prevalence of type 2 diabetes has risen dramatically in almost all the developed and developing countries. The International Diabetes Federation estimates that 425 million people around the world are suffering from diabetes diagnosed, making diabetes the largest global epidemic of the 21st century. According to Indian Council of Medical Research, India is known as the ‘diabetes capital of the world’. In India, approximately 101 million people are diabetics and 136 million people are prediabetic. The most concerning complication of T2DM at present is diabetic neuropathy. It can be peripheral, focal, proximal or autonomic. Globally, more than 40 million people suffer from neuropathy as a complication of T2DM. According to the American Diabetes Association (ADA), diabetic peripheral neuropathy (DPN) is defined as “the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes after the exclusion of other causesâ€. Common symptoms of DPN include significant deficits in tactile and pain sensitivity, kinesthesia, lower-limb proprioception, and vibration sense, caused by promotion of neuronal apoptosis and inhibition of nerve regeneration in diabetes. The nervous system is affected in DPN, which may lead to morbidity, thereby economic burden for diabetes care should be increased. DPN also accounts to about 40– 60% of lower extremity amputations. DPN symptoms can be subjective and short-term, so may go undetected. It is dominantly denoted by sensory changes in the “glove-and- stocking†distribution. The DPN prevalence cannot be fully studied, yet studies show a variation of about 10% to 90% in diabetic patients, depending on the criteria and methods used to define neuropathy. DPN has been almost discovered in 26% to 31% of surveys in T2DM patients in India. Treatment of DPN is challenging and the drugs available are scarce. The Gold standard method for diagnosing the DPN is Nerve Conduction Study (NCS) and the other diagnostic methods for assessing Quantitative sensory testing (QST) is CASE IV (WR Medical Electronics), Biothesiometer, Thermoaesthesiometer, TSA Neurosensory Analyser (Medoc Ltd), due to its feasibility and validity biothesiometer/Neurothesiometer is being used as an assessment tool for my study. The Daily functioning and sleep of approximately 25% of people with Diabetic Neuropathy gets interfered and it affects their Quality of Life. In DPN, there is a redox balance disruption of NADP+ and NADPH in T2DM due to aldose reductase enzyme. This causes an increase in sorbitol in our body which has been explained as a cause for the complications of T2DM. The sorbitol accumulation mainly occurs in the tissues like Retina, Kidney and Schwann cells which also lacks the enzyme Sorbitol dehydrogenase causes cell damage in T2DM patients. Tolrestat, Sorbinil and Zenerastat are aldose reductase inhibitors which had been used as drug in allopathy medication for the treatment of DPN. Due to its increased side effects, at present NSAIDS has been used as a drug of choice for DPN. Aldose reductase inhibitors that block the polyol pathway are the class of Medication given to slow or reverse the progression of neuropathy in Diabetes patients. Naturopathy is a cost-effective treatment, and a distinctive primary care medicine which promotes an overall well-being and the ability to overcome the disease. Naturopathy employs various therapies to treat the patient based on Panchamahabhuta theory. In my study, Massage and Aromatherapy are the therapies used for the intervention of DPN. Massage is the systemic rubbing and manipulation of the soft tissues of the body that produce effects on Vascular, Muscular and Nervous system. Aromatherapy is the use of essential oils that are extracted from plant parts which have a characteristic scent can be used to treat various diseases and improves general health. Aromatherapy massage denotes the technique of massage that is done by manipulating the soft tissues of the body by using an essential oil combined with a carrier oil. Clove Essential Oil (Syzygium aromaticum L.Myrtaceae) will be used for DPN patient in my study for Massaging the feet. Clove Essential Oil contains Eugenol about 50% and other compounds such as Eugenyl acetate, β Caryophyllene and α- humulene. Clove Essential Oil containing Eugenol being a potent inhibitor of Aldose reductase enzyme and an anti-oxidant will be diluted with carrier oil and used for DPN patients. The most common area affected in DPN is the feet and hands, majorly feet which when serious maybe prone for amputation. Foot Massage improves micro-circulation, thus helping in proper functioning of nerve cells can be used to reduce the severity of DPN. In addition to that, foot massage also helps to relieve pain, gives relaxation and reduce stress promoting a faster healing and improves sleep. Diabetic Peripheral Neuropathy (DPN) poses a significant challenge in the management of diabetes, affecting millions of individuals worldwide. Despite advancements in medical treatments, conventional approaches often fall short in providing satisfactory relief from the debilitating symptoms associated with DPN, including pain, numbness, and impaired mobility. Consequently, there is an urgent need for innovative and effective interventions that can augment the existing treatment modalities. This study aims to bridge this critical gap in knowledge by conducting a comprehensive comparative investigation on the therapeutic effects of foot massages incorporating clove essential oil and carrier oil among individuals suffering from diabetic peripheral neuropathy. The study will contribute valuable insights into the potential benefits of this novel intervention, thereby offering a promising avenue for improved management and alleviation of DPN-associated symptoms. |