| CTRI Number |
CTRI/2024/02/062297 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate effect of single ayurvedic drug therapy in Pandu (Iron deficiency Anaemia) |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial Study To Compare The Efficiency Of Yashtimadhu Kwath With Vasadi Kwath In Management Of Pandu (Iron Deficiency Anaemia) |
| 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 Sneha Santosh Karpe |
| Designation |
PG Scholar |
| Affiliation |
Tilak Ayurved Mahavidyalaya,Pune |
| Address |
Department Of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune- 11
India.
Department Of Kayachikitsa, Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune,
Maharashtra,
411011
India.
Pune
MAHARASHTRA
411011
India |
| Phone |
8652122761 |
| Fax |
|
| Email |
sneha13karpe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadanand V Deshpande |
| Designation |
HOD, Kayachikitsa Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya, Pune |
| Address |
Department Of Kayachikitsa, 1st Floor,Institutional Building,Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune.
Department Of Kayachikitsa, 1st Floor, Institutional Building,Tilak Ayurved Mahavidyalaya, Rasta Peth, Pune
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadanand V Deshpande |
| Designation |
HOD, Kayachikitsa Department |
| Affiliation |
Tilak Ayurvedi Mahavidyalaya, Pune |
| Address |
Department of Kayachikitsa, 1st Floor, Institutional Building,Tilak Ayurved Mahavidyalaya, Rasta Peth Pune- 11
Pune
Department Of Kayachikitsa, 1st Floor, Institutional Building,Tilak Ayurved Mahavidyalaya, Rasta Peth Pune- 11
Pune
MAHARASHTRA
411011
India |
| Phone |
9960071113 |
| Fax |
|
| Email |
drsvdeshpande61@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurved Mahavidyalaya, rasta Peth,Pune - 11 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya, |
| Address |
Rasta Peth, Pune --11 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sneha Santosh karpe |
Sheth Tarachand Ramnath charitable Ayurvedic Hospital,Pune |
OPD NO. 5,6,13 Department of kayachikitsa pune
Pune
MAHARASHTRA |
8652122761
sneha13karpe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Tilak Ayurved Mahavidyalaya Pune and Sheth tarachand Ramnath ayurved Hospital pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D759||Disease of blood and blood-formingorgans, unspecified. Ayurveda Condition: Iron Defieciency Anaemia, (2) ICD-10 Condition:D759||Disease of blood and blood-formingorgans, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu kwath, Reference: Sushrut uttartantra , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Women of reproductive age group of 15 to 49 years
patients diagnosed with iron deficiency anaemia
patients having symptoms of panduta, dourbalya, shwas,hritspandan, akshi koot shoth
patients having haemoglobin less than 12 |
|
| ExclusionCriteria |
| Details |
patients having haemoglobin less than 7
patient suffering from haematological disorder,gynacological diseases and systemic disorders
pregnant females and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Minimum 50% increase in Hb should be observed after the completion of the trial in 60 days |
Baseline, 15th day, 30th day, 45th day, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| recurrence of pallor,generalized weakness, dyspnoea,giddines |
60 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/02/2024 |
| 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="6"
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
|
Anaemia is the most common disorder of blood which affecting about a quarter of people globally. Iron deficiency anaemia is more common is females than males and children, womens of reproductive age group are more common. Prevalnce of anaemia among women of reproductive age in India is 52% . Yashtimadhu Kwath is choice of drug in pandu(Iron Deficiency anaemia) As it contains Yashtiadhu bharad, which helps to reduce the symptoms of pandu, by its properties like boosting immunity, enhances complexion and mosturizes skin it pacifies pitta, vat and vitiated rakta. enriched with such properties helps to heal injuries, relieve swelling, works as antidote as a poison.Subjecrive Parameters fot measurements - 1) Panduta 2) shirshoola 3) hrutaspandan 4) Shwas .overall assessment of results will be made by considering the collective effect on all the parameters and scoring criteria.
|