| CTRI Number |
CTRI/2019/01/017319 [Registered on: 31/01/2019] Trial Registered Prospectively |
| Last Modified On: |
26/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison Between Madhudaka And Manda In Obesity Management |
|
Scientific Title of Study
|
Comparative study to evaluate efficacy of Madhudaka and Manda in management of Sthaulya (Obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 148
1st Floor
Department of Kayachikitsa
Choudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atal Bihari Trivedi |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room No 148
1st Floor
Department of Kayachikitsa
Choudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
New Delhi
DELHI
110073
India |
| Phone |
9958046550 |
| Fax |
|
| Email |
abdratal8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shilpa Nagar |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Department of Kayachikitsa
Choudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
Choudhary Brham Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi
New Delhi
DELHI
110073
India |
| Phone |
09887227654 |
| Fax |
|
| Email |
drshilpanagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar ,New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Choudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi |
| Address |
Choudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Atal bihari Trivedi |
Choudhary Brahm Prakash Ayurved Charak Sansthan
Khera Dabar
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atal Bihari Trivedi |
Choudhary Brahm Prakash Ayurved Charak Sansthan New Delhi 110073 |
OPD No 2
Department of Kaya Chikitsa
New Delhi
DELHI |
9958046550
abdratal8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Madhudaka |
40 patients will be given Madhudaka, Madhu will be taken Purana (1yr.old).
Dose of Purana Madhu according to API - 10ml.
Formation of Madhudaka :
Ingredients -Madhu ( Honey),Udak ( water).
Preparation - Take 240ml or 1 glass of water and add 10 ml of Honey to it.
Dose - Daily 1 glass of honey mixed water early morning empty stomach.
Duration - 30 days
|
| Comparator Agent |
Manda |
40 patients will be given Manda, for preparation of Manda Shalishasthika will be taken Purana (1 year old).
Formation of Manda :
Ingredients - Puran shalishashtika(rice), water(14times), Sauwarchal Lvana (salt).
Preparation - 1 cup of broken (coarse powder)Puran Shalishasthika to which add 14 times of water and is cooked on the low flame gas, Sauwarchal is added to taste. The flame is stopped once the Puran Shali are cooked, than collect only water, it is Manda.
Dose - 250 ml of Manda, early morning empty stomach.
Duration -30 days
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
BMI 30 to 40kg/sqm
WHR>0.85
symptom of sthaulya Chalasphikaudarstana (visible movement in area of buttocks, belly, breast) , Alasya (lack of enthusiasm), Kshudraswasa (Difficulty in breathing), Daurblya (Weakness),Nidraadhikya (Excessive sleep),Swedadhikya (Excessive sweating)
Daurgandhya (Bad odour), Snigdhangata (Oily luster of body)
Atipipasa (Excessive thrust) , Atikshuda (Excessive hunger)
|
|
| ExclusionCriteria |
| Details |
1. Patients with secondary obesity(Hypothyroidism, Diabetes, Drug induced etc.)
2. Patients with Renal, Hepatic and Cardiac involvement.
3. Pregnant and Lactating women.
4. Any other condition which may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lipid Profile
Weight |
Day1
Day15
Day30
Day45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
BMI
Waist hip ratio |
day1 day15 day30 day45 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
01/02/2019 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is conducting for the purpose of MD dissertation award. Obesity is a life style disorder and the fifth leading risk of global deaths, worldwide Obesity has more than doubled since 1980. it is associated with
future risk of increased breathing difficulties, increase risk of fractures,
hypertension, cardiovascular disease, insulin resistance and psychological
effects. A person having
excessive deposition of Meda and Mamsa Dhatu at the site of Sphik(buttock),
Udar(belly), Stan (breast) is termed as Sthool Purusha. in this study to see the effect of Madhudaka and Manda
and to generate evidence for use of Madhudaka and Manda
in the management of Sthaulya. Study design: single center ,Open label, Randomized clinical
trial Inclusion
Criteria is age
between 21 - 50 years Female BMI
ranging 30-40kg/m2
4. WHR -
Women >0.85
5. Patient
having symptoms of Sthaulya-
Chalasphikaudarstana
(visible movement in area of buttocks, belly,
breast) , Alasya (lack of enthusiasm), Kshudraswasa (Difficulty
in breathing), Daurblya (Weakness),Nidraadhikya (Excessive sleep),Swedadhikya
(Excessive sweating)
Daurgandhya (Bad
odour), Snigdhangata (Oily luster of body)
Atipipasa (Excessive
thrust) , Atikshuda (Excessive hunger)
Exclusion
Criteria is secondary obesity(Hypothyroidism, Diabetes, Drug induced etc; Patients
with Renal, Hepatic and Cardiac involvement; Pregnant
and Lactating women. Sample size: Two
groups with 40 patients in each group. Group A- 40 patients will be given Madhudaka,
Madhu will be taken Purana (1yr.old). Group B- 40 patients will
be given Manda, for preparation of Manda Shalishasthika will be
taken Purana (1 year old).Duration :-30 days assessment criteria is symptoms of sthaulya and weight, lipid profile, BMI, waist hip ratio and assess on day1, day15, day30 and day45. primary outcome is weight and lipid profile and secondary outcome is BMI and waist hip ratio. |