| CTRI Number |
CTRI/2022/12/048302 [Registered on: 20/12/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the rasayana effect of Amrit Bhallataka and Ashwagandhadi lehya in akaalaja jara (Premature ageing)
|
|
Scientific Title of Study
|
A randomised comparative clinical trial to evaluate the rasayana effect of Amrit Bhallataka and Ashwagandhadi lehya in akaalaja jara (Premature ageing) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyoti Rani |
| Designation |
PhD Scholar |
| Affiliation |
National Institution of Ayurveda , Deemed to be university (De-Novo) |
| Address |
Room no 209 Department of Agad Tantra National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan
National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7495098825 |
| Fax |
|
| Email |
jyotisurya2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anita Sharma |
| Designation |
Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no 206 Department of Agad Tantra National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan
National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Rani |
| Designation |
phd scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room no 206 Department of Agad Tantra National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan
National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
7495098825 |
| Fax |
|
| Email |
jyotisurya2014@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawar singh gate, Amer road, Jaipur (Rajasthan)- 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 Jyoti Rani |
National Institute of Ayurveda Hospital,Jaipur |
Room no. 209,Dept. of Agad Tantra, National Institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur (Rajasthan)-302002
Jaipur
RAJASTHAN |
7495098825
jyotisurya2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E46||Unspecified protein-calorie malnutrition. Ayurveda Condition: VARDHAKYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrit Bhallatak, Reference: chakardatta- Rasayan adhikar, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi lehya, Reference: AFI, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 48 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.having 3 symptoms of premature ageing
2.Patients willing to give written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients with any type of psychiatric disorder, Alzheimer’s disease,
parkinsonism etc.
2.Patients with any major diseases like carcinoma, heart disease, DM, hyperhypothyrodism, hypertension etc.
 Patients giving present history of addiction to drug, tobacco or alcohol.
 Pitta prakriti person will be excluded on the basis of CCRAS short prakriti performa
 Pregnant and lactating females |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in score of Akaalaj jara lakshana
|
7 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
change in WHO-Quality of Life Bref
Oxidative stress- SOD level
Hb
LFT
|
48 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 2 |
|
Date of First Enrollment (India)
|
27/12/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 Patients showing more than 3 sign of premature ageing will be selected and would be randomly divided in two groups. In first group Amrit Bhallatak and in second group, Ashawagandhadi lahya will be given for 48 days. before and after treatment assessment for premature ageing sign, QOL questioner and laboratory investigation - SOD, Hb, LFT would be done. |