| CTRI Number |
CTRI/2025/08/092777 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Herbal Treatments for Anemia: A Study on Vaasadi and Triphala Kwatha |
|
Scientific Title of Study
|
A Clinical Comparative Study To Evaluate The Effect Of Vaasadi Kwatha And Triphala Kwatha In The Management Of Vataja Pandu vis-à-vis 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 Akshatha |
| Designation |
PG Scholar |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre |
| Address |
Department Of Kayachikitsa In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2 , Ramagondanahalli, yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
8296254235 |
| Fax |
|
| Email |
akshathadesai909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana CP |
| Designation |
HOD |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre |
| Address |
Department Of Kayachikitsa In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2 , Ramagondanahalli, yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9900063059 |
| Fax |
|
| Email |
aayurvedalaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana CP |
| Designation |
HOD |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre |
| Address |
Department Of Kayachikitsa In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2 , Ramagondanahalli, yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9900063059 |
| Fax |
|
| Email |
aayurvedalaya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2, Ramagondanahalli, yelahanka, Bangalore, Karnataka, India. pin - 560064. |
|
|
Primary Sponsor
|
| Name |
Dr Akshatha |
| Address |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2, Ramagondanahalli, yelahanka, Bangalore, Karnataka, India. pin - 560064. |
| 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 |
| Dr Akshatha |
Ramakrishna Ayurvedic Medical College Hospital And Research Centre |
Department Of Kayachikitsa In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2 , Ramagondanahalli, yelahanka, Bangalore.
Bangalore
KARNATAKA |
08296254235
akshathadesai909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramakrishna Ayurvedic Medical College Hospital And Research Centre Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Kwatha, Reference: Kaviraj Govind Das Sen , Bhaishajya Ratnavali Edited with Sidhi Prada Hindi Commentary ,by Prof.sidhi Nanda Mishra, Choukamba Surbharati Publictions Edition -2007, chapter no -12 Shloka no - 5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vaasadi Kwatha, Reference: Kaviraj Govind Das Sen , Bhaishajya Ratnavali Edited with Sidhi Prada Hindi Commentary ,by Prof.sidhi Nanda Mishra, Choukamba Surbharati Publictions Edition -2007, chapter no -12 shloka no - 23, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the classical signs and symptoms of vataja panduroga as per classical text and vis-à-vis Iron deficiency anemia in modern science.
2. Patients aged between 18 to 60years.
3. Patients of either gender.
4. Hb% ranging from ( in men 7-13gm/dl and in women 7-12 gm/dl) |
|
| ExclusionCriteria |
| Details |
1. Patients having Systemic and Infectious Diseses.
2. pregnant and lactating mother.
3. patient with Genetic ,Congenital,Acute blood loss,Hemolytic disorders and Aplastic Anemia,
4. Hb% Level below 7gm/dl. |
|
|
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 |
| Improvement in laboratory parameters which includes,CBP,SERUM IRON |
1st day,15th day,30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
17/08/2025 |
| 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="2"
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
|
This is a postgraduate academic clinical study conducted to compare the Clinical effect of Vaasadi kwatha and Triphala kwatha in the Management of Vataja Pandu with special reference to iron deficiency anemia. vataja pandu is a condition in which there is vaivarnata, dourbalya, shrama, hridaya spanadana, shwasa etc symptoms which affects the overall health and quality of life.
In Current study two classical ayurvedic formulations are being compared in efficacy, for the treatment of Vataja Pandu. The two formulations being Triphala Kwatha and Vaasadi Kwatha.
The primary objective of this clinical study is to assess and compare the lab parameters signs and symotoms in the condtion of Vataja Pandu.
Here the participants will be randomly allocated into two groups. The treatment will be given for 30 Days followed by assessment on 15th and 30th day. Post study follow up will be conducted on 90th day.
The result of this clinical study will help us to evaluate the comparative efficacy of the above mentioned drugs in Vataja Pandu / Iron Deficiency Anemia. |