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A CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KSHEERABALA 101 AVARTHI AND KSHEERABALA THAILA IN THE MANAGEMENT OF DIABETIC PERIPHERAL NEUROPATHY

A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF KSHEERABALA 101 AVARTHI AND KSHEERABALA THAILA IN THE MANAGEMENT OF DIABETIC PERIPHERAL NEUROPATHY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038430
Enrollment
30
Registered
2021-12-03
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: E104- Type 1 diabetes mellitus with neurological complications Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: KSHEERABALA 101 AVARTHI THAILA AND KSHEERABALA THAILA: KSHEERABALA THAILA IS A CLASSICAL AYURVEDIC FORMULATION WITH BALA GOKSHEERA AND THILA THAILA AS INGREDIENTS. AVARTHANA OF THE FOR

Sponsors

Dr SHEMA SARA KURIEN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 METABOLICALLY STABLE DIABETIC SUBJECTS WITH SYMPTOMATIC DIABETIC PERIPHERAL NEUROPATHY 2 SUBJECTS OF ALL GENDER BETWEEN THE AGE GROUP OF 20-75 YEARS 3 SUBJECTS FULFILLING THE DIAGNOSTIC CRITERIA 4 SUBJECTS WHOSE HBA1C IS BETWEEN 6.5 TO 10%

Exclusion criteria

Exclusion criteria: 1 SUBJECTS WHERE HBA1C >10% 2 SUBJECTS WITH OTHER CAUSES OF POLYNEUROPATHY OTHER THAN DIABETES 3 SUBJECTS SUFFERING FROM INFECTIOUS DISEASES AND NON-HEALING ULCER/ ULCERS OF FOOT 4 ANY SYSTEMIC ILLNESS THAT CAN INTERFERE WITH THE COURSE OF TREATMENT

Design outcomes

Primary

MeasureTime frame
1 CHANGES IN DIABETIC NEUROPATHY SYMPTOM (DNS) QUESTIONNAIRE SCORE 2 CHANGES IN DIABETIC NEUROPATHY EXAMINATION (DNE)SCORE 3 CHANGES IN VISUAL ANALOG SCALE Timepoint: 30TH DAY,45TH DAY—

Secondary

MeasureTime frame
CHANGES IN QUALITY OF LIFE (WHO QoL-BREF)Timepoint: 30th DAY—

Countries

India

Contacts

Public ContactDr SHEMA SARA KURIEN

SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH

Lakshmimp1981@gmail.com9448173128

Outcome results

None listed

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