Effect of Traditional Ayurvedic Formulation Divya Cystogrit in patient with Cysts, Fibroids and Benign tumor.

Phase 3

Active, not recruiting

• Conditions: Other benign neuroendocrine tumors,

• Registration Number: CTRI/2023/01/048769
• Lead Sponsor: Patanjali Research Foundation Trust

Brief Summary

This study is an Open-label, prospective observational study in order to verify the safety and efficacy of the formulation of  Divya Cystogrit Tablet in patients suffering from Cysts, benign tumors, and fibroids.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• The age of the subject will be 18-70 years.
• Subjects with a malignant tumor confirmed by histopathology or cytology.
• Willing to participate and give consent for the study.
• Capability for complete compliance and completion of follow-up.

Exclusion Criteria

• Known allergy to any of the active ingredients or excipients of the study drug, or have a history of allergy to other opioids or NSAIDs and their related ingredients...
• The subject with a known history of gastrointestinal bleeding or perforation, a positive result of fecal occult blood test during screening period, serious cardiovascular diseases, a history of an acute ischemic or hemorrhagic stroke within 6 months prior to screening, a history of significant psychiatric disorders, such as schizophrenia and depression.
• History of alcohol abuse or drug abuse including opioids have significant opioid contraindications.
• Expected pregnancy or breastfeeding.
• The subject who is not willing to provide consent and comply with the protocol.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe the changes in quality of life in cancer patients taking Divya Cystogrit as per the treatment protocol by an ayurvedic practitioner.	Baseline, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
Changes in the Numeric Pain Rating Scale (NPRS), EORTC QOL C-30, Depression-Anxiety Stress Scale (DASS-21) and Medication Adherence Report Scale (MARS).

Trial Locations

Locations (2)

Patanjali Wellness Center; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Yog Gram; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Wellness Center

🇮🇳Hardwar, UTTARANCHAL, India

Dr Nikhil Mishra

Principal investigator

8700567087

nikhil.mishra@patanjali.res.in