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Efficacy andtolerability Study of Amrutanjan advanced joint muscle plus spray for pain relief

Phase 1
Completed
Conditions
Health Condition 1: M259- Joint disorder, unspecified
Registration Number
CTRI/2021/09/036890
Lead Sponsor
Amrutanjan Health Care Limited Tamil Nadu India
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
48
Inclusion Criteria

1.Patients of either sex aged above 18 years.

2.Patients who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily.

3.Patients who had been diagnosed with acute and chronic localized musculoskeletal pain and joint pain disorders.

Exclusion Criteria

Patients presenting with any of the following will not be included in the trial.

1.Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.

2.Subject with active skin lesions or other skin diseases.

3.Subject with history of uncontrolled diabetes (HbA1C of more than 9)

4.Known allergy to compounds of investigational product.

5.Fracture, Ligament tear, sports injury patient will be excluded

6.Subject undergoing physiotherapy session will be excluded.

7.Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.

8.Participation in an investigational drug trial in the30 days prior to the screening visit.

9.Patients of vulnerable group (children, lactating mother, elderly >80 years, handicapped, seriously ill, mentally challenged).

10.History of drug or alcohol abuse during the last 6 months.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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