| CTRI Number |
CTRI/2023/01/048769 [Registered on: 05/01/2023] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Traditional Ayurvedic Formulation Divya Cystogrit in patient with Cysts, Fibroids and Benign tumor. |
|
Scientific Title of Study
|
"Efficacy of Traditional Ayurvedic Formulation (Divya Cystogrit) in Cysts, Fibroids and Benign tumor patients: a single arm, open-label, prospective, observational study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Purva Soni |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Institute |
| Address |
Panchkarma, Patanjali Wellness, Patanjali Yogpeeth Phase-2, Delhi-Haridwar National Highway, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7302254791 |
| Fax |
|
| Email |
purvasoni92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nikhil Mishra |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Institute |
| Address |
Opp. Patanjali Yogpeeth-1, Maharishi Dayanand Gram, Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8700567087 |
| Fax |
|
| Email |
nikhil.mishra@patanjali.res.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Mishra |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Institute |
| Address |
Opp. Patanjali Yogpeeth-1, Maharishi Dayanand Gram, Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8700567087 |
| Fax |
|
| Email |
nikhil.mishra@patanjali.res.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Patanjali Research Institute, Governed by Patanjali Research Foundation trust, Patanjali Yogpeeth Trust, Haridwar Uttarakhand, Pin-249405 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nikhil Mishra |
Patanjali Wellness Center |
Panchkarma, Patanjali Wellness, Patanjali Yogpeeth Phase-2, Delhi-Haridwar National Highway, Haridwar, Uttarakhand, India- 249405
Hardwar
UTTARANCHAL |
8700567087
nikhil.mishra@patanjali.res.in |
| Dr Nikhil Mishra |
Patanjali Yog Gram |
Panchkarma, Patanjali Yoggram, Village Aurangabad, Near SIDCUL Roshnabad, Haridwar, Uttarakhand- 249402
Hardwar
UTTARANCHAL |
8700567087
nikhil.mishra@patanjali.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D3A8||Other benign neuroendocrine tumors, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Divya-Cystogrit, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 450(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: LUKEWARM WATER/MILK), Additional Information: NA |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
Changes in the Numeric Pain Rating Scale (NPRS), EORTC QOL C-30, Depression-Anxiety Stress Scale (DASS-21) and Medication Adherence Report Scale (MARS).
|
Baseline, Day 30th and Day 60th |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. |