| CTRI Number |
CTRI/2020/12/029917 [Registered on: 18/12/2020] Trial Registered Prospectively |
| Last Modified On: |
17/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Pharmaco-clinical trial to study the effect of Shigru Kanda Twaka and Patra in management of obesity |
|
Scientific Title of Study
|
A Comparative Pharmaco-clinical study of Shigru(Moringa oleifera Lam.)Kanda Twaka and Patra w.s.r.to Sthaulya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha chalmela |
| Designation |
Post graduation scholar |
| Affiliation |
Govt dhanwantri ayurvedic medical college and hospital |
| Address |
Dravyaguna department opd no 52
Dravyaguna department opd no 52
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
7879004854 |
| Fax |
|
| Email |
dr.nehan20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiromani Mishra |
| Designation |
Associate professor |
| Affiliation |
Govt dhanwantri ayurvedic medical college and hospital |
| Address |
1st floor dravyaguna department Govt dhanwantri ayurvedic medical college Mangalnath road Ujjain
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9893158853 |
| Fax |
|
| Email |
shiromishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shiromani Mishra |
| Designation |
Associate professor |
| Affiliation |
Govt dhanwantri ayurvedic medical college and hospital |
| Address |
1st floor dravyaguna department Govt dhanwantri ayurvedic medical college Mangalnath road Ujjain
Ujjain
MADHYA PRADESH
456006
India |
| Phone |
9893158853 |
| Fax |
|
| Email |
shiromishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt autonomous Dhanwantri Ayurvedic College and Hospital mangalnath road Ujjain m p pin code 456006 |
|
|
Primary Sponsor
|
| Name |
Govt Dhanwantri Ayurvedic College and Hospital Ujjain |
| Address |
Mangalnath road Ujjain Madhya pradesh |
| 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 |
| Neha Chalmela |
Govt Dhanwantri Ayurvedicl Hospital |
OPD No 52 Dravyaguna Department Govt Dhanwantri Ayurvedicl Hospital Chimanganj Thane Ke Pichhe
Ujjain
MADHYA PRADESH |
7879004854
0
dr.nehan20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical Committee Govt Dhanwantri Ayurvedic Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: sthaulya, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1 Shigru Kanda Twaka Churna orally
2 Shigru Patra Churna orally |
1 Shigru Kanda Twaka Churna 3gm/BD before meal with luke warm water daily for 8 week
2 Shigru Patra Churna orally3gm/BD before meal with luke warm water daily for 8 week |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having classical sign and symptom of sthaulya (obesity)
2 Patients having BMI between 25-35
3 waist hip ratio |
|
| ExclusionCriteria |
| Details |
1 Patients below 18 years and above 50 years
2 BMI below 25 and above 35
3 pregnant women and lactating mother
4 Patients having long term steroid treatment
5 Patients having history of serious systemic disorders like Cardiac disorders, Renal & Hepatic impairment, Hypertension, thyroid and PCOD, any type of Cancer, Diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in classical sign and symptoms of sthaulya (At the time of baseline and at the end of the treatment |
Total Study period 12 months and Treatment period 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of change in the clinical parameters (on 30th and 60th day) |
Total Study period 12 months and Treatment period 8 weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/12/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomized interventional comparative pharmaco- clinical study of Shigru (Moringa oleifera Lam) Kanda Twaka and Patra w.s.r. to Sthaulya. Total 60 patients will be enrolled in present study. Selected patients will be divided in to two groups on the basis of computer generated randomization.GROUP A 30 patients will be given Shigru Kanda Twaka churna 3gm BD orally before meal with luke warm water for 8 weeks
GROUP B 30 patients will be given Shigru Patra churna 3gm BD orally before meal with luke warm water for 8 weeks |