| CTRI Number |
CTRI/2019/04/018765 [Registered on: 24/04/2019] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study Of Kamdhenu Rasa Vati in Anemia |
|
Scientific Title of Study
|
“Randomized Controlled Trial Of Kamdhenu Rasa Vati In The Management Of Pandu Roga With Special Reference to Iron Deficiency Anemia†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yogesh T Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
MAMs Sumatibhai Shah Ayurved College O.P.D. No. 2 Malwadi Hadapsar Pune Kayachikitsa O.P.D.
MAHARASHTRA
411028
India
Kayachikitsa OPD
Govt. Ayurved College
Vazirabad
Nanded 431601
Pune
MAHARASHTRA
411028
India |
| Phone |
9423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh T Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
MAMs Sumatibhai Shah Ayurved College O.P.D. No. 2 Malwadi Hadapsar Pune Kayachikitsa O.P.D.
MAHARASHTRA
411028
India
Kayachikitsa OPD
Govt. Ayurved College
Vazirabad
Nanded 431601
Pune
MAHARASHTRA
411028
India |
| Phone |
9423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yogesh T Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved College |
| Address |
MAMs Sumatibhai Shah Ayurved College O.P.D. No. 2 Malwadi Hadapsar Pune Kayachikitsa O.P.D.
MAHARASHTRA
411028
India
Kayachikitsa OPD
Govt. Ayurved College
Vazirabad
Nanded 431601
Pune
MAHARASHTRA
411028
India |
| Phone |
9423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Govt.Ayurved College,
Vazirabad, Nanded 431603 |
| Type of Sponsor |
Government 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 YOGESH TUKARAM KOTANGALE |
Govt. Ayurved College, Nanded |
Kayachikitsa OPD,
Govt. Ayurved College
Vazirabad,
Nanded
Nanded
MAHARASHTRA |
9423218193
drytk@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D508||Other iron deficiency anemias, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kamdhenu Rasa vati
|
250 mg once a day for 30 days
with Madhu 5 ml
in the morning |
| Comparator Agent |
Tab. Ferrous Ascorbate and folic acid |
100 mg
with Madhu |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) The patients having age between 20 to 50 years irrespective of caste, religion, socio economical status.
2) The patients having symptoms of Pandu roga viz. Panduta (pallor), Hridspandan (palpitations), Akshikut shoth (periorbital edema)
3) Patient with Hb% between 8.00 gm to 10.9 gm
4) Patients of both male and female gender. |
|
| ExclusionCriteria |
| Details |
1) Hemoglobin < 8 gm% in both males and females.
2) Patients suffering from known hematological disorders such as sickle-cell anemia and thalassemia.
3) Patients suffering from known systemic disorders such as hypertension, diabetes mellitus, AIDS, various bleeding disorders, cancer and any other infectious & chronic diseases.
4) Pregnant and lactating females.
5) Patients who have undergone any minor or major surgical procedure in preceding 3 months. 6) Patients who are already being administering any hematinic drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Randomized Controlled Trial Of Kamdhenu Rasa Vati In The Management Of Pandu Roga With Special Reference to Iron Deficiency Anemia |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Does Kamdhenu Rasa Vati increase and maintain Hb% for 1 month after withdrawal of the treatment in Pandu Roga (Iron deficiency Anemia) |
90 days |
|
|
Target Sample Size
|
Total Sample Size="214"
Sample Size from India="214"
Final Enrollment numbers achieved (Total)= "214"
Final Enrollment numbers achieved (India)="214" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
24/04/2019 |
| Date of Study Completion (India) |
15/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Anemia is a major public health problem worldwide and also in India. Iron deficiency anemia (IDA) is one of the leading risk factors for disability and mortality worldwide, affecting both developing and developed countries. Ayurveda offers medicinal preparations which positively treat the basic pathology. Detail description regarding chikitsa tatva in Pandu roga emphasizes ‘Agnivruddhi’ more rather than plain Loha Dhatu vruddhi. This kind of treatment is effective for the long-term curing the root cause of the disease. Hence, the effect continues even after the treatment regimen is stopped. Kamdhenu Rasa vati contains Kajjali, Vatsanabh, Louha bhasma, abhrak bhasma and Trikatu. The ingredients have the property of Agnivruddhi and reduces the symptoms of Pandu Roga. Considering all the above factors, ‘Kamdhenu Rasa Vati’ an Ayurvedic preparation mentioned in Rasayogsagar has been selected as the trial medicine to treat Pandu Roga and study its effects statistically in copmparision with Tab. Ferrous Ascorbate and Folic acid. |