| CTRI Number |
CTRI/2024/07/071655 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Difference between Vidharikhand vati and Ashwagandha Vati in Treatment of Underweight |
|
Scientific Title of Study
|
Evaluation of the comparative efficacy of Vidarikand vati (Pueraria tuberosa DC) vs. Ashwagandha vati (Withania somnifera Linn) in Karshya (underweight): Randomized controlled trial. |
| Trial Acronym |
A randomised controlled experiment was conducted to assess the comparative effectiveness of Vidarikand vati and Ashwagandha vati in treating karshya (underweight). |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrNikita Rathod |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
4420001
India |
| Phone |
9284352979 |
| Fax |
|
| Email |
nikitarathodpbn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNikita Rathod |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
4420001
India |
| Phone |
9284352979 |
| Fax |
|
| Email |
nikitarathodpbn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Kuchewar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Hirapur Wardha
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
4420001
India |
| Phone |
09420998747 |
| Fax |
|
| Email |
vkuchewar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre salod Salod Hirapur Wardha
Pincode 442001
State Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
| Address |
Mahatma Gandhi Ayurved College Hospital and Research Centre salod Salod Hirapur Wardha
Pincode 442001
State Maharashtra
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikita Rathod |
Mahatma Gandhi Ayurved College Hospital and Research Centre |
Room no 30
Departmentof
Kayachikitsa
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9284352979
nikitarathodpbn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethics Committee salod wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:E440||Moderate protein-calorie malnutrition. Ayurveda Condition: KARSY, (2) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: KARSYAMÂ (KEVALAVATA), (3) ICD-10 Condition:E43||Unspecified severe protein-caloriemalnutrition. Ayurveda Condition: KARSHNYAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidarikand Vati, Reference: Charaksamhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha Vati, Reference: Charaksamhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients willing to Participate in the Study and give written informed
consent
2 Age between 20 to 30 years of either sex
3 Patients having BMI in between 14 to 19 kilogram meter squire
4 Patients having Hemoglobin more then 8 gram per deciliter |
|
| ExclusionCriteria |
| Details |
Patients with acute complications like Cirrhosis of liver Pancreatitis
Tuberculosis Diabetes mellitus Diabetes insipidus Hyperthyroidism
Severe Anaemia Hb less than 8gm/dl Other systemic diseases like
CKD CHD and other Immuno Compromised disease like HIV
Rheumatoid arthritis etc |
|
|
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
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Bruhaniya effect of
Vidarikand vati and ashwagandha vati in BMI body weight arm and
waist circumference of both the groups on 0th 30th 60th and 90th day of treatment |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Bruhaniya effect of
Vidarikand vati & ashwagandha vati in BMI body weight arm and
waist circumference of both the groups after 120th day of treatment |
One Hundred And Twenty Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
08/04/2025 |
| 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="1"
Days="10" |
|
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
|
he volunteers will be informed about the study protocol. willing participants will be randomly selected as per lottery method. clinical research format will be prepared and validated. prior to the study approval will be taken from IEC, MGACHRC salod hirapur Wardha and CTRI registration will be done. After selection, participants will be tested individually and selected according to selection criteria. they have divided into two groups the trial is a parallel-group, randomized double blind double dummy clinical standard control trial. it will include 90 days treatment period and 90th day follow-up period. |