| CTRI Number |
CTRI/2024/11/076493 [Registered on: 08/11/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effectiveness of Rohitakasava (An Ayurvedic medicine) in Anemia |
|
Scientific Title of Study
|
A Comparative Pharmaceutico-Analytical Study Between Two Formulations of Rohitakasava and Its Clinical Evaluation W.S.R to Pandu Roga |
| 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 Bhoomika V |
| Designation |
PG Scholar |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD No 3
KVG Ayurveda Medical College and Hospital
Sullia
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9606279373 |
| Fax |
|
| Email |
deepavinodsingh123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purushotham K G |
| Designation |
Professor and HOD |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
Department of Rasashastra and Bhaishajya Kalpana
KVG Ayurveda Medical College and Hospital
Sullia
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
7204832002 |
| Fax |
|
| Email |
drpurushothamkg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhoomika V |
| Designation |
PG Scholar |
| Affiliation |
KVG Ayurveda Medical College and Hospital |
| Address |
OPD No 3
KVG Ayurveda Medical College and Hospital
Sullia
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9606279373 |
| Fax |
|
| Email |
deepavinodsingh123@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG Ayurveda Medical College and Hospital
Ambate adka
Sullia
Dakshina Kannada
Karnataka, India
574327 |
|
|
Primary Sponsor
|
| Name |
Dr Bhoomika V |
| Address |
OPD No 3
KVG Ayurveda Medical College and Hospital
Sullia
Dakshina Kannada
Karnataka
574327 |
| 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 Bhoomika V |
KVG Ayurveda Medical College and Hospital |
OPD No 3
Kayachikitsa
Sullia
Dakshina Kannada
Karnataka
574327
Dakshina Kannada
KARNATAKA |
9606279373
deepavinodsingh123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KVG Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D649||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: Rohitakasava 1, Reference: Gadanigraha, Route: Oral, Dosage Form: Asava, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -(2) Medicine Name: Rohitakasava 2, Reference: Gadanigraha, Route: Oral, Dosage Form: Asava, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Hb level above 7gm/dL and below 11gm/dL
2) Patients with lakshanas of Pandu Roga as mentioned in classics |
|
| ExclusionCriteria |
| Details |
1) Hb level below 7gm/dL and above 11gm/dL
2) Pregnancy and Lactation
3) Severe Renal/Hepatic/Cardiac disease
4) Any continuing blood loss diseases
5) Patients with Type 1 and Type 2 Diabetes Mellitus
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Patient improved health condition
Increased hemoglobin level
Decreased classical lakshanas of Pandu roga |
28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient improved health condition before the completion of treatment |
21st 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 |
|
Date of First Enrollment (India)
|
16/11/2024 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A randomized parallel study was conducted with 30 patients,
ensuring a balanced comparison between treatment groups to evaluate the
effectiveness of the interventions of Pandu Roga.
Pandu Roga is a disease in which there is altered skin color(Panduta).
About 8.8% of global population is affected in all age groups.
There are many Shamanaushadhis mentioned in classical text of
Ayurveda indicated in Pandu Roga. Aushadha to be
selected in Pandu Roga should posses properties like Deepana,
Pachana, Kapha-Pittashamaka, Vatanulomaka, Rakta prasadaka, Rakta
shodhaka, Rasayana.
Rohitakasava is one such formulation mentioned in Gadanigraha
Asavadhikara indicated in Pandu Roga and more.
There are two references of Rohitakasava, one formulation with
ingredients of Rohitaka, Triphala, Dhataki pushpa, Panchakola, Guda and
other formulation contains Rohitaka, Dhataki pushpa, Trijata,
Panchakola, Guda.
As both are indicated in Pandu Roga with slight changes in
drugs and their ratio, the formulation which is efficacious and of standard
quality has to be evaluated. |