| CTRI Number |
CTRI/2024/12/078179 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to evaluate efficacy of loha gudadi gutika and ferrous ascorbate + folic acid in pandu specifically iron deficiency anemia |
|
Scientific Title of Study
|
A randomised controlled clinical trial to evaluate efficacy of loha gudadi gutika in the management of pandu with special reference to iron deficiency anemia |
| 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 Vaibhav shankarrao Eknar |
| Designation |
PG scholar |
| Affiliation |
PDEAs college of Ayurveda and Research centre nigdi |
| Address |
Department of kayachikitsa
3rd floor room no. 6 PDEAs college of Ayurveda and Research centre
sector 25 nigdi
PUNE
MAHARASHTRA
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8554064042 |
| Fax |
|
| Email |
Vaibhaveknar81@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrinda hitendra kurande |
| Designation |
Assistant professor |
| Affiliation |
PDEAs college of Ayurveda and Research centre nigdi pune |
| Address |
Department of kayachikitsa 3rd floor PDEAs college of Ayurveda and Research centre
sector 25 nigdi
PUNE
MAHARASHTRA
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
7722030521 |
| Fax |
|
| Email |
vrinda.kurande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav shankarrao Eknar |
| Designation |
PG scholar |
| Affiliation |
PDEAs college of Ayurveda and Research centre nigdi pune |
| Address |
Department of kayachikitsa 3rd floor room no. 6 PDEAs college of Ayurveda and Research centre
sector 25 nigdi
PUNE
MAHARASHTRA
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8554064042 |
| Fax |
|
| Email |
Vaibhaveknar81@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS college of Ayurveda and Research centre pradhikaran nigdi pune |
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurveda and Research centre nigdi pune |
| Address |
PDEAs college of Ayurveda and Research centre
sector 25 nigdi
PUNE
MAHARASHTRA
411044 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Vaibhav shankarrao Eknar |
Ayurved Rugnalaya and Sterling multispeciality hospital pune |
Kayachikitsa department OPD no 17 ayurved Rugnalaya and Sterling multispeciality hospital sector 27 pradhikaran nigdi pune
pune 411044
Pune
MAHARASHTRA |
8554064042
Vaibhaveknar81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| College of Ayurveda and Research centre nigdi pune Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Loha gudadi gutika, Reference: Sahastrayoga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -buttermilk ), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Ferrous ascorabate folic acid | Dose 101 mg once a day for 60 days with water route oral |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with classical symptoms like panduta,ayasenshwas , akshikoot shoth , hrid dravata,shwasa, daurbalya ,agnimandya
2. Hb percentage for female range between 7-10gm/dl and for male between 7-11gm/dl |
|
| ExclusionCriteria |
| Details |
1. Garbhini pandu
2. patients with known case of aplastic anemia ,sickle cell anaemia
3. pregnant women ,lactating mother
4. patient with severe systemic disorders
5. patients associated with other diseases like kamala and halimaka
6. patients with known case of leukemia metastasis cancer |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the effectiveness of loha gudadi gutika with ferrous ascorbate + folic acid in pandu with special reference to iron deficiency anemia |
60 days study with 3 follow ups on 1st day 30th day and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of drugs if any |
60 days study with 3 follow ups .on 1st day 30th day and 60th day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
22/12/2024 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Anemia is most common disease seen in general population. According to the national family health survey (2019-21) is 25 % men and 57% women in India suffering from anemia. Modern drugs associated with gastrointestinal side effects such as constipation or bloating and piles too .to introduce new drug from ayurveda for pandu having minimal side effects .although lots of work have been done on management of pandu still alternative medicines are required because different set of prakruti Loha gudadi gutika is introduced . |