| CTRI Number |
CTRI/2022/09/045268 [Registered on: 06/09/2022] Trial Registered Prospectively |
| Last Modified On: |
05/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of nagaradi churna on kaphaja pandu w.s.r to iron deficiency anemia |
|
Scientific Title of Study
|
Randomized open controlled clinical trial of nagaradi churna on kaphaja pandu w s r to anemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Diksha Chandrakant Sonwane |
| Designation |
PG scholar |
| Affiliation |
Yashwant ayurvedic medical College and Research Center kodoli |
| Address |
Yashwant Ayurvedic Medical College and Research Center Kodoli Tal Panhala Dist Kolhapur
Yashwant Ayurvedic medical College and Research Center Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387424907 |
| Fax |
|
| Email |
dikshasonwane7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suryakiran Wagh |
| Designation |
MD kayachikitsa |
| Affiliation |
Yashwant ayurvedic medical College and Research Center Kodoli |
| Address |
kayachikitsa department Yashwant Ayurvedic Medical College and Research Center Kodoli Tal Panhala Dist Kolhapur
kayachikitsa department Yashwant Ayurvedic Medical College and Research Center Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822846910 |
| Fax |
|
| Email |
Suryakiran_wagh@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Diksha Sonwane |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic medical College and Research Center Kodoli |
| Address |
Yashwant Ayurvedic Medical College and Research Center Kodoli Tal Panhala Dist Kolhapur
Yashwant Ayurvedic Medical College and Research Center Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7387424907 |
| Fax |
|
| Email |
dikshasonwane7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic college post graduate training and Research Center, Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Diksha Sonwane |
| Address |
Yashwant Ayurvedic Medical College and Research Center Kodoli Tal Panhala Dist Kolhapur |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| Nil |
Nil |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Diksha Chandrakant Sonwane |
Diksha Chandrakant Sonwane |
Room no 17 kayachikitsa department Yashwant Ayurvedic medical college and research centre kodoli,Panhala
Kolhapur
MAHARASHTRA |
7387424907
dikshasonwane7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Yashwant Ayurvedic college,PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D648||Other specified anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Ferrous sulphate | Rout oral
Dosage 100 mg
Frequency once a day
Duration 90 days
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagaradi churna , Reference: Yog ratnakar , Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -gomutra ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Gender-Patients of any gender will be included.
2.Age-16 yrs to 60 yrs
3.Patients those having Lakshanas of kaphaja Pandu.
4.Hb% ranges above 7gm/dL to 10gm/dL.
5.Patient who shows Panduta,Guruta,Tandra, shithilata, Alasya ,Aruchi, shwas will be included for study.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women, Lactating mothers.
2.Anemia associated with other known history of diseases like Nephrotic Syndrome, Liver Cirrhosis, Ascites, Congestive Cardiac Failure, Acute Coronary Syndromes, Leprosy, Auto- Immune Disorders etc.
3.Patients having known history of Chronic Blood loss conditions such as Malena, Haemetemesis, Haemorrhagic Piles, Menorrhagia, Metrorrhagia, etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Scales of following symptoms
1)Panduta
2)Guruta
3)Tandra
4)Alasya
5)Shwas
6)Aruchi
7)Shithilata |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase hemoglobin |
90 days |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/09/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As iron deficiency anemia is the most common type of the anemia worldwide. In conventional medicine various forms of treatment are used. There are some adverse effects of allopathic treatment. As the anemia is very common prevalent disease in the society, so to get better alternative, an ayurvedic herbo-mineral medicine, Nagaradi Churna will be subjected to a clinical trial in the anemic patients. The present study was carried out to carry the efficiency of an Ayurveda herbomineral compound “NAGARADI CHURNA†|