| CTRI Number |
CTRI/2023/08/056111 [Registered on: 04/08/2023] Trial Registered Prospectively |
| Last Modified On: |
11/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative clinical study of wild and cultivated varieties of Amalaki for Rasayana effect in the Akalaja jara |
|
Scientific Title of Study
|
A comparative clinical assessment of wild and cultivated varieties of Amalaki (Phyllanthus emblica Linn.) for Rasayana effect in the management of Akalaja jara |
| 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 Jyoti Dashrathbhai Bhagiya |
| Designation |
M.D. Scholar 2nd year |
| Affiliation |
Government Ayurved College, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
8866158609 |
| Fax |
|
| Email |
jyotibhagiya18598@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dilip K Jani |
| Designation |
H.O.D. and Professor |
| Affiliation |
Government Ayurved College, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9925941861 |
| Fax |
|
| Email |
drdilipjn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suman Singh |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College, Vadodara |
| Address |
Post graduate department of Dravyaguna Government Ayurved
College, Ajwa road, Dhanvantari marg, Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9510172204 |
| Fax |
|
| Email |
snghsmn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Ajwa road, Dhanvantari marg, Panigate,
Vadodara-390019 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved Hospital Vadodara |
| Address |
Government Ayurved Hospital, Ajwa road,Dhanvantari Marg,
Panigate, Vadodara-390019 |
| 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 Jyoti D Bhagiya |
Government Ayurved Hospital, Vadodara |
OPD and IPD,
Dravyaguna
Department
Vadodara
GUJARAT
Vadodara
GUJARAT |
8866158609
jyotibhagiya18598@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurved College and Hospital Vadodara |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers possessing Akalaja jara lakshana |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Wild Amalaki (Phyllanthus emblica linn)) and Krushna tila (Sesamum indicum Linn), Reference: Vaidhya manorama, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ghruta and Madhu), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gujarat Anand-2 variety of Amalaki and Krushna tila, Reference: Vaidhya manorama, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ghruta and madhu), Additional Information: - | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: NA-5 variety of Amalaki and Krushna tila, Reference: Vaidhya manorama, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ghruta and Madhu), Additional Information: - | | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: NA-7 variety of Amalaki and Krushna tila, Reference: Vaidhya manorama, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ghruta and Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers between the ages of 18 to 30 years with clinical features of Akalaja Jara.
Irrespective of gender
Volunteers with 4 or more symptoms of Akalaja Jara.
Volunteers who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Volunteers having age less than 18 years and more than 30 years
Volunteers with any type of psychiatric disorder like Alzheimer’s disease, Parkinsonism, Schizophrenia etc.
Volunteers with any diseases like carcinoma, IHD, Hepatic and renal insuffiency, IBS or Dhatukshayatva involved in the pathophysiology of disease like Madhumeha, Rajyakshama etc.
Pregnant women, Lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Utsahhani |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Twak rukshta, Vali, Khalitya, Palitya, Agnisad |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| Date of Study Completion (India) |
07/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical study has obtained Institutional
Ethics committee clearance (GAC/VAD/IEC/83/2023, Date-24/01/2023) and
registered at Clinical Trial Registry of India, ICMR, New Delhi, vide CTRI/2023/08/056111,
[Registered on 04/08/2023]. Study type was single blind parallel arm randomized
clinical trial. 48 volunteers were enrolled
and divided into four groups (i.e., Group-A, Group-B, Group-C and Group-D) and
12 volunteers in each group were allocated. Total 45 volunteers (i.e. 12
volunteers in group A, 10 volunteers in group B, 12 volunteers in group C and
11 volunteers in group D) have completed the study. All individual four groups
were having significant difference percentage in Akalaja Jara. Data analysis of cardinal
symptoms showed that, for Twaka Rukshta Group-C (NA-5 variety) had
better percentage of result i.e. 33% compared to other trial groups. For Khalitya
Group-A (Wild variety) had better result i.e. 33% compared to other trial
groups. For Agnisaad Group- A (Wild variety) had better result i.e. 58%
compared to other trial groups. For Utsahhani 8% result was observed in
Group-A (Wild variety) and Group-C (NA-5) compared to other trial groups. In
Group-A and Group-D, statistically significant difference was found in Agnisaad.
While,
non-significant difference observed in-between groups. In overall effect of
therapy mild improvement was observed 25%, 20%, 16.67% and 18.18% in Group-A,
Group-B, Group-C and Group-D respectively and no change was observed 75%, 80%,
83.33% and 81.81% in Group-A, Group-B, Group-C and Group-D respectively. |