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A clinical trial to determine the effect of Reflexology therapy in addition to the pharmacological drugs for managing patients suffering from Diabetic Neuropathy

Randomized Clinical Trial (RCT) on the effect of reflexology in the management of patients suffering from diabetic neuropathy: Case studies

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001091
Enrollment
71
Registered
2010-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Diabetic Neuropathy

Interventions

Intervention1: Reflexology therapy which will be of 30 minutes duration twice a day, during which the specific reflex areas on feet are stimulated along with the pharmacological drugs.: Control Inter

Sponsors

Indian Council of Medical Research ICMR New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age group: any age 2. Both of sex 3. Patients who were residents of Delhi or have arrangement for stay over Delhi for a minimum duration 1 month. And during the follow-up period, the proper correspondence should be available to the laboratory for getting the information about their health status. This is required for monitoring their health in response to reflexology. 4. Patients who have signed in informed consent proforma 5. Patients with Blood sugar level: greater than or equal to 120mg/decilitre(Fasting) and greater than or equal to 200mg/deciliter (post prandial) for more than 1 occasion 6. Patients with documented peripheral diabetic neuropathy.

Exclusion criteria

Exclusion criteria: 1. Patients non-resident of Delhi or not having any arrangement to stay in Delhi during the training period which was 2½ months -3 months 2. Patients with end organ damage (viz., gangrene, toes or foot amputation) due to diabetes/any cause 3. Patients not willing to sign informed consent from 4. Patients suffering from over-neuropathy 5. Patients with other chronic disorders like malignancy, T.B., asthma or any communicable disease.

Design outcomes

Primary

MeasureTime frame
Neuropathy pain score measured by Visual Analogue Scale (VAS) in the range of 0-10, where 0 indicates no pain while 10 indicates excruciating painTimepoint: 6 months

Secondary

MeasureTime frame
Quality of Life in neuropathy as measured by neuroQOL, responses on the reflex areas, objective and subjective parameters. Abnormal features recorded on the reflex areas: (i) Tenderness (ii) Hollowness formation (iii) Abnormal pigmentation (iv) Swelling (v) Corn formation Objective parameters: (i) Blood sugar level F & PP (ii) Glycosylated HbA1c (iii) Blood pressure (iv) Frequency of urination (v) Nerve conduction velocity (vi) Vibration sensitivity (vii) Thermal sensitivity Subjective parameters (standard questionnaire): (i) Numbness in the legs/ feet (ii) Tingling sensation (iii) Difficulty in walking (iv) Difficulty in standing (v) Burning sensation Timepoint: 6 months for all the secondary outcome measures

Countries

India

Contacts

Public ContactDr (Mrs) Manjari Tripathi

Head & Associate Professor

drkrishnadalal@gmail.com01126593215

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026