| CTRI Number |
CTRI/2025/02/081354 [Registered on: 27/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to evaluate the add on effect of Shunthi Ghritha with Navayasa loha in Panduroga vis-a-vis Iron deficiency anemia. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to evaluate add on effect of Shunthi Ghritha with Navayasa Loha in Panduroga vis-a-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 Vajreshwari |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room no 5, Department of Kyachikitsa, Department of PG Studies Division, Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani,Anekal Taluk, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
09740128548 |
| Fax |
|
| Email |
mallivajreshwari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vajrala Venkat Ram Reddy |
| Designation |
Professor and HOD |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room no 5, Department of Kyachikitsa, Department of PG Studies Division, Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani,Anekal Taluk, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
8099993599 |
| Fax |
|
| Email |
ramreddyv9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vajreshwari |
| Designation |
PG Scholar |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
Room no 5, Department of Kyachikitsa, Department of PG Studies Division, Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani,Anekal Taluk, Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
09740128548 |
| Fax |
|
| Email |
mallivajreshwari@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, Bangalore, KaRNATAKA, India-560105 |
|
|
Primary Sponsor
|
| Name |
Dr Vajreshwari |
| Address |
Sushrutha Ayurvedic Medical College and Hospital, Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bangalore, KaRNATAKA, India-560105 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sushrutha Ayurvedic Medical College and Hospital |
Prashanthi Kuteera, Jodi Bingipura, Jigani, Anekal Taluk, Bangalore, 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 Vajreshwari |
Sushrutha Ayurvedic Medical College and Hospital |
Room No 4, Department of Kayachikitsa, Out Patient Department,Prashanthi Kuteera Jodi Bingipura, Jigani, Anekal Taluk, Bangalore
Bangalore
KARNATAKA |
9740128548
mallivajreshwari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committtee SAMC and H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E638||Other specified nutritional deficiencies. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navayasa loha , Reference: charaka chikitsa Panduroga adhikara , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Hot water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunti Ghritha, Reference: Sahasrayoga Ghritha prakarana , Route: Oral, Dosage Form: Ghrita, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Hot water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of both gender between the age group of 20-60 years who fit into diagnostic criteria will be included.
Subjects presenting with pratyatma lakshana of Panduroga that include panduta, agnimandya, dourbalya, shrama, arohanaayasa, gatrashula, aruchi, bhrama, pindikodwestana, karnaksweda .etc.
Subjects with mild to moderate anemia with Hb concentration of 8-11.99% in females and 8-12.99% in males.
Subjects who are willing to provide informed consent will be included.
|
|
| ExclusionCriteria |
| Details |
Subjects having severe anemia with Hb less than 8gm% will be excluded from the study.
Subjects having any other systemic diseases and under medications which interfere with the disease process and the present clinical trial will be excluded.
Pregnancy, lactation and puerperal stage will be excluded.
Subjects suffering from bleeding disorders, infective, metabolic or endocrinal disorders and autoimmune diseases will be excluded.
Subjects known case of Sickle cell anemia, Thalassemia, Leukemia, Hemophilia, Sideroblastic anemia, etc. will be excluded. |
|
|
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms of Panduroga assessed by subjective criteria |
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)
|
20/03/2025 |
| 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 a randomized, comparative clinical trail to evaluate the add on effect of Shunthi ghritha 12 grams twice daily along with Navayasa loha 500 mg twice daily in Group A with minimum of 15 patients, Navayasa loha 500 mg twice daily in Group B with minimum of 15 patients in the management of Panduroga vis-a-vis Iron deficiency anemia for a period of 30 days. The primary outcome is reduction in symptoms of Panduroga and the secondary outcome is improvement in subjects condition. |