| CTRI Number |
CTRI/2023/04/051705 [Registered on: 18/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study by using loha amrutama with navayasa churna in iron deficiency anaemia. |
|
Scientific Title of Study
|
An open randomised controlled clinical study on efficacy of Loha Amrutama(Rasa ratnakar) and Navayasa Churna(Charak) in Pandu roga with special reference to Iron deficiency anaemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNikita Sunil Singh |
| Designation |
PG scholar |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Kayachikitsa Department, 4th floor,Ayurved Mahavidyalaya Sion
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
8879324863 |
| Fax |
|
| Email |
nikitasingh4863@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnaya Ashish Pathrikar |
| Designation |
HOD and guide |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Kayachikitsa Department, 4th floor,Ayurved Mahavidyalaya Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnaya Ashish Pathrikar |
| Designation |
HOD and guide |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Kayachikitsa Department, 4th floor,Ayurved Mahavidyalaya Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurved Mahavidyalaya Sion
besides sion railway station
mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
DrNikita Sunil Singh |
| Address |
Kayachiktsa Department, 4th floor,Ayurved Mahavidyalaya Sion |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrNikita Sunil Singh |
Sheth R.V. ayurvedic hospital and Sheth V.M.charitable dispensary |
Ayurved Mahavidyalaya Sion
kayachikitsa department 4th floor opd no 9 and 10,
besides sion railway station
Mumbai
Mumbai
MAHARASHTRA |
8879324863
nikitasingh4863@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvidya Prasarak Mandal IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E611||Iron deficiency. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Loha amrutama, Reference: Rasaratnakar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navayasa churna, Reference: Charak samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -honey), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having Prayatma lakshanas of pandu roga
Pandutha
Arohan Ayasa
Pindikodweshtana
Klama Hb Percentage between 7-12g% male & 7-10g% in females. |
|
| ExclusionCriteria |
| Details |
Pregnant women & lactating mothers.
Patients suffering from infectious diseases.
Patients who has acute or chronic blood loss.
Patients with systemic disorders that would interfere with course of the study.
All types of secondary, congenital and hereditary anaemia.
Patients who do not give consent for treatment. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To check the improvement in the symptoms mentioned in the subjective and objective criteria on respective follow ups. |
10th day,20th day,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the adverse effect of Loha amrutama on respective follow ups. |
1Oth day,20th day,30th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
23/04/2023 |
| 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)
|
Not Yet Recruiting |
| 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
|
Iron deficiency anaemia is most common nutrition deficiency disorder worldwide. According to National family health survey data the incidence of anaemia is 79 % the national family health survey data suggests that the prevalence of anaemia in adolscent is 56%. In Ayurveda iron deficiency anaemia can correlate with Pandu roga. Ayurveda combinations indicated for Pandu comprise of other Drugs along with Loha/ Mandur bhasma. So, beauty of Ayurveda preparation lies in assuring digestion, metabolism and excretion (after complete utilisation) of the doing without any untoward reactions and side effects. In this trial, I have selected two drugs for my clinical trial with almost equal quantity of Loha bhasma(to avoid bias) .In due course of trial, I shall study mode of action, indication of the drug and efficacy as well. |