CLINICAL TRIAL TO EVALUATE EFFICACY & SAFETY OFPALSINURON CAPSULE FOR TREATMENT OF DIABETIC NEUROPATHY

The clinical trial was designed to assess the efficacy and safety of Proprietary Ayurvedic medicine Cap. Palsinuron in Diabetic Polyneuropathy.

Null Hypothesis:

Proprietary Ayurvedic medicine Cap. Palsinuron is not effective in the management of Diabetic Polyneuropathy.

Alternate Hypothesis:

Proprietary Ayurvedic medicine Cap. Palsinuron is effective in the management of Diabetic Polyneuropathy.

Study Design:

Open label, interventional, single centric Phase IV clinical trial to evaluate Efficacy & safety of Proprietary Ayurvedic medicine Cap. Palsinuron capsule for treatment of diabetic neuropathy with proper arrangements for withdrawals.

Settings:

Known Patients of Type II Diabetes Mellitus diagnosed with diabetic peripheral sensorimotor neuropathy (DPSN) will be incidentally selected from Out-patient department of Kayachikitsa, Parul Ayurveda Hospital, Vadodara and referred cases from other departments/ physicians of the city.

Source/s of monetary or material support:

·         SG Phytopharma, Kolhapur, Maharashtra; Funding and legal support

·         Parul Institute of Ayurveda, Faculty of Ayurveda, Parul University, Vadodara, Gujarat; Infrastructure, HR and Technical and Settings

 Eligibility/ Inclusion Criteria:

1.         Metabolically stable diabetic patients with symptomatic diabetic sensorimotor polyneuropathy (DSPN)

2.         Patients of either sex between the age group of 35-65 years.

3.         HbA1c not exceeding 11

Exclusion Criteria:

1.         Patients who are insulin dependent.

2.         Patients with other metabolic and endocrinal disorders.

3.         Patients with other causes of Polyneuropathy.

4.         Patients suffering from infectious diseases.

5.         Patients with non healing ulcer/ulcers.

6.         Patients with Diabetic Polyneuropathy in stage N3 of Dyck’s staging[ii]

Dyck’s staging of diabetic polyneuropathy is as follows:

• N0       -           No neuropathy
• N1a     -           Signs but no symptoms of neuropathy
• N2a     -           Symptomatic mild diabetic polyneuropathy; sensory, motor, or

autonomic symptoms; patient able to heel walk

• N2b     -           Severe symptomatic diabetic polyneuropathy (as in N2a, but

patient unable to heel walk)

• N3       -           Disabling diabetic polyneuropathy

Patients fulfilling the criteria for diagnosis will be included in the study and subjected to thorough interrogation and physical examination.

Laboratory Investigations:

The following basic studies will be carried out on all included subjects in order to rule out other causes of neuropathy and to assess the impact of the therapy;

• Hb, Complete blood cell count, ESR
• Complete metabolic panel; LFT, RFT, Lipid Profile
• Routine Urinalysis
• Plasma glucose and Urine glucose estimation – Fasting and 2 hr. Postprandial
• Glycated Hemoglobin

Other investigations will be done whenever necessary to exclude other causes of peripheral sensorimotor polyneuropathy.

History and other relevant important data will be recorded in special clinical research proforma.

Interventions:

Target Sample size (n) -          Minimum 50 completing the schedule

Drug                            -           Proprietary Ayurvedic medicine Cap. Palsinuron

Dosage                                    -           2 Capsules twice daily after food

Anupana                      -           Sukhoshna Jala

Duration                      -           3 months

Note:   The management of NIDDM in the selected subjects will be continued during the study as per the advice of concerned physicians/diabetologists. If the patients are already on treatment for DPSN with other medications, those cases were included only after discontinuation of drugs and at least 5 days of drug free interval.

Ethical clearance: Ethical clearance will be obtained from Institutional Ethics Committee of Parul Institute of Ayurveda, Parul University before enrolment of the first subject.

Registration: This study will be registered in Clinical Trial Registry of India (CTRI; www.ctri.nic.in) prospectively.

Informed Consent: An informed written consent will be obtained from all included subjects.The consent form will prepared in Accordance with the guidelines[iii] of WHO Research Ethics Review Committee (ERC). This Informed Consent Form has two parts:

• Patient information sheet and
• Certificate of consent (signed by the subject, will be attached with the research proforma.)

Outcome measures/ Criteria for Assessment:

Primary outcomes:

• Changes in Neuropathy Symptom Score[iv] (NSS) and
• Michigan Neuropathy Screening Instrument[v] (MNSI).
• Quality of Life; WHO QoL (BREF)

Time points: The outcomes were measured after screening at Baseline (BT) and at the end of 3 months (AT).

Withdrawal criteria:

Subjects who develop acute complications of Diabetes like ketoacidosis or any other serious diseases or develop serious adverse events to the interventions in the study period will be withdrawn from the study and referred to competent centers.

Rescue medications:

Subjects developing any serious events interim to the study will to be advised suitable rescue medications. For minor complaints regular medicines from the institutional hospital will be advised.

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[i]Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010;340:c332.

[ii] Dyck PJ. Detection, characterization and staging of Polyneuropathy: assessed in diabetics. Muscle Nerve 1988; 11: 21-32.

[iii]  http://www.who.int/rpc/research\_ethics

[iv] Ziegler D, Diabetic peripheral neuropathy and sexual dysfunction. In. Goldstein BJ, Muller-Wieland D editors. Type 2 Diabetes Principles and Practice. 2Ed. New York: Informa healthcare; 2008.  pp. 277-312.

[v]MNSI, University of Michigan, 2000. Available online at www.med.umich.edu/mdrtc/profs/ documents / svi/ MNSI. pdf