| CTRI Number |
CTRI/2025/04/084808 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical Study to know the efficacy of Taramandura guda in the management of Sthoulya (Obesity ) Associated with Iron Deficiency Anemia. |
|
Scientific Title of Study
|
Open Labelled Single Arm Clinical Study to evaluate the efficacy f Taramandura guda in the management of Sthoulya (Obesity ) Associated with 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 Basappa B kadadi |
| Designation |
PG Scholor |
| Affiliation |
sushrutha ayurvedic medical college and hospital |
| Address |
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
Bangalore
KARNATAKA
560105
India |
| Phone |
09108213849 |
| Fax |
|
| Email |
bbkadadi1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basappa B kadadi |
| Designation |
PG Scholor |
| Affiliation |
sushrutha ayurvedic medical college and hospital |
| Address |
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
Bangalore
KARNATAKA
560105
India |
| Phone |
9108213849 |
| Fax |
|
| Email |
bbkadadi1234@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basappa B kadadi |
| Designation |
PG Scholor |
| Affiliation |
sushrutha ayurvedic medical college and hospital |
| Address |
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
Bangalore
KARNATAKA
560105
India |
| Phone |
09108213849 |
| Fax |
|
| Email |
bbkadadi1234@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa, Department of PG studies Division, Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bengaluru,
Karnataka, India - 560105
|
|
|
Primary Sponsor
|
| Name |
Dr. Basappa B kadadi |
| Address |
Room NO 5, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore, Karnataka, India, 560105 |
| Type of Sponsor |
Other [self ( other)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sushrutha Ayurevedic Medical College and Hospital |
Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bengaluru, Karnataka, India - 560105 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Basappa B Kadadi |
Sushruta Ayurvedic Medical cillege and Hospital |
Room NO 4, Department of Kayachikitsa,Department of PG studies, Division,Sushrutha Ayurevedic Medical College and Hospital Prashanti Kuteera,Jodi Bingipura, Jigani, Anekal Taluk Bangalore.
kARNATAKA
560105
India
Bangalore
KARNATAKA |
09108213849
bbkadadi1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee SAMC and H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E660||Obesity due to excess calories. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Taramandura guda , Reference: Chakradatta , Route: Oral, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: sukoshna jala ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects who fit into Diagnostic Criteria
2. Subjects between the age group of 25 to 45 years of either sex.
3. Subjects having BMI of 23 to 34.9kg/m2will be included.
4. Female Subjects having Hemoglobin less than 12 will be included.
5. male subjects having Hemoglobin less than 14 will be included.
6. Subjects willing to participate in the study will be included. |
|
| ExclusionCriteria |
| Details |
Subjects having BMI equal or more than 35kg/m2 will be excluded.
2. Obesity due to any Endocrinal Disorders will be excluded.
3. Drug induced Obesity will be excluded.
4. Any Systemic illness that interfere with the course of Intervention will be excluded.
5. Subjects of Atisthoulya will be excluded.
6. Subjects having Hemoglobin less than 7 will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of sthoulya( obesity) assessed by subjective criteria, improvement of iron deficiency anemia is assessed by laboratory investigations |
0 and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjects condition assessed by objective criteria |
30th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/10/2025 |
| 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 study is open labelled single arm clinical study to evaluate the efficacy of Taramandura guda in the management of sthoulya ( obesity) associated with Iron deficiency Anemia. in this study 6 gm of Taramandura guda is given in 3 divided doses with sukoshna jala for 30 subjects for 30 days and The primary outcome is reduction in symptoms of sthoulya ( obesity) associated with iron deficiency and the secondary outcome is improvement in subjects condition. |