An Assessment of Ashwagandhadi Yoga in the Management of Chemotherapy Induced Peripheral Neuropathy (CIPN) with respect to Ojovikriti and Vata-Pitta Vikara

Phase 2

• Conditions: Health Condition 1: G620- Drug-induced polyneuropathy

• Registration Number: CTRI/2022/09/045712
• Lead Sponsor: Department of Kayachikitsa Faculty of Ayurveda IMS BH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Aged between 15-60 years including either sex.

2.Diagnosed cases of chemotherapy induced peripheral neuropathy.

3.Patient willing to participate in the above trial and giving informed consent.

4.Patients screened with Nerve Conduction study (NCS) and Surface Electromyography(EMG),

(when necessary).

Exclusion Criteria

1.Aged higher than 60 years including either sex.

2.Cases with the co-occurrence of neuropathy before the

start of chemotherapy (e.g., diabetic neuropathy)

3.Pregnant and lactating women.

4.Patients with known case of Diabetes Mellitus

5.Patients with low level of vitamin B-12( <200 ng/100 ml)

6.Patients with impaired renal function with reduced

clearance

7.Patients with implanted cardiac pacemakers and

defibrillators.

8.Patients exposed exposure to other neurotoxic

chemotherapeutic agents already

9.Patients with independent, direct cancer-associated

neuropathy.

10.Patients who took any other medication or discontinue the

trial period without information of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subjective symptoms assessment by European Organization for Research and Treatment of Cancer, EORTC QLQ ââ?¬â?? CIPN20 (includes symptoms of vata-pitta janya vikara)Timepoint: 3 months <br/ ><br>Treatment course will be given for 3 months & 3 follow ups -before treatment, after 45 days, and after 3 months will be recorded

Secondary Outcome Measures

Name	Time	Method
1)Objective assessment by, <br/ ><br>a. Nerve Conduction Study (NCS) <br/ ><br>b. Electromyography (EMG) <br/ ><br>c. Hematological study <br/ ><br> <br/ ><br>Timepoint: 3 Months <br/ ><br>Treatment course will be given for 3 months & 3 follow ups -before treatment, after 45 days, and after 3 months will be recorded