| CTRI Number |
CTRI/2023/09/057653 [Registered on: 14/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Ayurvedic Formulation Patanjali Haemogrit Vital in subjects with Anemia. |
|
Scientific Title of Study
|
Efficacy of Indian Ayurvedic Formulation Haemogrit Vital in subjects with Anemia: A Single-Arm, Open-Label, Prospective, Interventional Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Devasena K M |
| Designation |
Medical Research Associate |
| Affiliation |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation, Near Patanjali Yogpeeth-1, NH-58 Haridwar, Uttarakhand Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
07012421624 |
| Fax |
|
| Email |
drdevasenabamsmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devasena K M |
| Designation |
Medical Research Associate |
| Affiliation |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation, Near Patanjali Yogpeeth-1, NH-58 Haridwar, Uttarakhand Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
07012421624 |
| Fax |
|
| Email |
drdevasenabamsmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhawna sharma |
| Designation |
Clinical Research Associate |
| Affiliation |
Patanjali Research Foundation |
| Address |
Patanjali Research Foundation, Near Patanjali Yogpeeth-1, NH-58 Haridwar, Uttarakhand Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
07807907352 |
| Fax |
|
| Email |
bhawna.sharma@patanjali.res.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation governed by Patanjali Research Foundation Trust |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation governed by Patanjali Research Foundation Trust |
| Address |
Patanjali Research Foundation, Opp. Patanjali Yogpeeth-1, Maharishi Dayanand Gram, Delhi-Haridwar National Highway, Near Bahadrabad, Haridwar, Uttarakhand, India-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 Devasena K M |
Patanjali Wellness |
PATANJALI WELLNESS LIMITED, CIN No.-U74120 UR2009 PTCO32907
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
07012421624
drdevasenabamsmd@gmail.com |
| Dr Devasena K M |
Patanjali Yoggram |
Yog Naturopathy Panchkarma Treatment & Research Centre (Yoggram) Subsidiary unit of Patanjali Yogpeeth., Near Sidcul, Aurangabad, Haridwar (Uttarakhand), PIN Code: 249402.
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
07012421624
drdevasenabamsmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Approved |
| Institutional Ethics 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:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Haemogrit Vital, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 600(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult male and female population having mild or moderate anemia defined as follows:
Hb levels: Female: mild: 11.0-11.9 g/dl, moderate: 8.0–10.9 g/dl.; Males: mild: 11.0–12.9 g/dl, moderate: 8.0–10.9g/dl.
2.Subjects aged from 18 years and above.
3. Signed informed consent prior to study specific procedures.
4.Availability and willingness to complete all study visits and procedures per protocol.
|
|
| ExclusionCriteria |
| Details |
1. Having Sickle Cell Anemia, Thalassemia Minor, Pernicious Anemia, Aplastic Anemia.
2. Having Hemophilia, & Other Hemolytic diseases.
3. Erythropoietin treatment within 8 weeks prior to the screening visit.
4. Pregnancy or Breast Feeding.
5. Chronic inflammation eg. RA, AS, Gastro-intestinal disorders eg. UC, IBD, Hemorrhoids.
6. Having Chronic Kidney Disease, Chronic Liver Disease, Psychiatric Disorders.
7. Any Malignant Conditions eg. Myeloma, Lymphoma etc.
8. Intake of iron preparations 4 weeks prior to screening.
9. Known hypersensitivity to any excipients of the intervention.
10. Participation in any other interventional trial within 4 weeks prior to screening.
11. Patients planning surgery within the trial phase or receiving a blood transfusion a week prior to the screening visit.
12. Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator’s opinion.
13. Any other medical condition that, in the opinion of the investigator, makes the patient incompetent to participate in the trial or places the patient at potential risk, e.g. any chronic comorbidity.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Mean change from baseline in Hemoglobin levels at Day 60. |
Baseline, Day 30, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean Changes in MFSI-SF, BFI, SF-12, PSQI & also the changes from baseline to Day 60 in CBC Count. |
Baseline, Day 30, Day 60 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2023 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 a single-arm, open-label, prospective, interventional study. In this study, 100 participants will be enrolled aged 18 years and above. Participants will receive intervention with medication for 60 days. The primary outcome involves Mean change from baseline in Hemoglobin levels at Day 60 and secondary outcome involves Mean changes in MFI-SF, BFI, SF-12, PSQI. |