| CTRI Number |
CTRI/2021/05/033808 [Registered on: 25/05/2021] Trial Registered Prospectively |
| Last Modified On: |
11/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of ayurvedic medicines (Punarnavadi Kwath and Navaka Guggulu) in Obesity. |
|
Scientific Title of Study
|
A Comparative Study to Evaluate the Efficacy of Punarnavadi Kwath and Navaka Guggulu in Medoroga (obesity) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof N R singh |
| Designation |
Prof. (Department of Kayachikitsa) |
| Affiliation |
Ch.Brahm Prakash Ayurvedic Charak Sansthan |
| Address |
Room no. 146 ,Department of Kayachikitsa ,Ch.Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar (Najafgarh)
New Delhi
INDIA
Khera dabar ,Najafgarh (South west Delhi)
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof N R singh |
| Designation |
Prof. (Department of Kayachikitsa) |
| Affiliation |
Ch.Brahm Prakash Ayurvedic Charak Sansthan |
| Address |
Room no. 146 ,Department of Kayachikitsa ,Ch.Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar (Najafgarh)
New Delhi
INDIA
Khera dabar ,Najafgarh (South west Delhi)
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chirag Arora |
| Designation |
MD Scholar (Department Of Kayachiktsa) |
| Affiliation |
Ch.Brahm Prakash Ayurvedic Charak Sansthan |
| Address |
Room no. 146 ,Department of Kayachikitsa ,Ch.Brahm Prakash Ayurved Charak Sansthan ,Khera Dabar (Najafgarh)
South West Delhi
New Delhi
INDIA
South West
DELHI
110073
India |
| Phone |
9354097960 |
| Fax |
|
| Email |
drchiragarora4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera dabar New Delhi 110073 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Autonomous Ayurvedic Medical college and Hospital under Govt of NCT of Delhi |
| Type of Sponsor |
Other [Autonomous Ayurvedic Medical college and Hospital under Govt of NCT of Delhi] |
|
|
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 |
| Prof Dr NR singh |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
Room no 146 department of Kayachikitsa
South West
DELHI |
9560659728
naimishraj@yahoo.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:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Navaka gugglu |
40 Patients will be selected randomly for this group and they will be treated with Navaka guggulu.
Dose- 2tab each of 500mg orally twice a day after meals. Duration of therapy will be 30 days. |
| Intervention |
Punarnavadi Kwath |
40 Patients will be selected randomly for this group and they will be treated with Punarnavadi kwath .
Dose- 10 gm of kwath bolied with 160 ml water at low flame when 40 ml lukewarm prepared kwath remains then take orally twice a day before meals.
Duration- 30 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)BMI ranging from 30 to 40 kg/m2
2)Patient having few or more of the clinical features of Medoroga.
-Short (repeated) breathing
-Thirst
-Delusions
-Sleepiness
-Suddden obstruction to breath
-Laxity of the body
-Excessive Hunger and Sweating
-Foul Odour of the body
-Decreased Vitality
-Decreased Sexual Power of the Body
3)Patient willing to partcipate and provide signed informed consent. |
|
| ExclusionCriteria |
| Details |
1)Patients reporting with known case of serious renal,hepatic and cardiac anomalies.
2)pregnant and lactating women
3)patients having any malignancy
4)patients who are not willing to participate with 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 |
Reduction in Scoring Patterns of sign and sypmtoms of Medoroga.
1) Chala Sphika Udara Stana
2)Alasya/Utsah hanilack of Zest)
3)Kshudra Shwasa(Difficulty in Breathing)
4)Daurbalya(weakness)
5)Nidra adhikya(Excessive Sleeping)
6)Swedadhikya(Excessive sweating)
7)Daurgandhya(Bad Odour)
8)Snigdhangata(oil lustre of body)
9)Atipipasa(Excessive Thirst)
10)Atikshuda(Excessive Hunger)
11)Angagaurava(Heaviness of body) |
Day 1
Day 15
Day 30
Day 45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in weight,BMI,Waist circumference,Hip Circumference,Waist Hip Ratio,Serum Reduction in weight,BMI,Waist circumference,Hip Circumference,Waist Hip Ratio,Serum VLDL,S.LDL,S.Triglycerides,S.Total Cholesterol,and an increase in Serum HDL |
Day 1
Day 15
Day 30
Day 45 |
|
|
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)
|
03/06/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Medoroga means a disease in which Medo dhatu is deranged and known as Medo dushti. Main involving Dosha and Dushya in Medoroga Samprapti are Kapha Dosha and Medo dhatu which leads to Medovaha Sroto dushti.It occurs due to lack of physical exercise ,sleeping day time and intake of kapha increasing diet are converted into sneha (fatty acids) which leads to increase of fat,since the increased meda blocks channels and other dhatus are not properly nourished as a result fat is further increased and the person become incapable of daily routine activities efficiently. Due to exceesive increase in Meda and Mamsa the person’s buttocks,belly and breasts become pendulous and his vigour is depleted. Medoroga may be correlated with obesity in modern medical science. Obesity is abnormal or excessive fat accumulation that may impair health .Overweight is a BMI greater than or equal to 25 kg/m2 and a BMI greater than or equal to 30 kg/m2 is defined as obesity. This study is aimed to compare the efficacy of Punarnavadi kwath and Navaka Guggulu in reduction of BMI and Lipid profile. total number of Patients is 80 .40 in each group .In group A , punarnavadi kwath orally 40ml twice a day empty stomach in morning and 4 hours after lunch , In group B Navaka Guggulu orally 2 tab twice a day ,1 hour after meals in morning and evening. Criteria for Assessment-1)Subjective Parameters - Scoring Pattern will be adopted to obtain the percentage relief for sign and symptoms of Medoroga to assess the efficacy of therapy. 2)Objective Parameters-Weight, BMI scale, Waist circumfrence ,Hip Circumference, Waist Hip Ratio, Lipid Profile. Lab investigations- Lipid profile ,it includes Serum Total Cholesterol, S. Triglycerides, S. LDL, S.VLDL, S.HDL . Expected Outcome variables -Reduction in weight, BMI, Waist circumference , Hip circumference ,Waist Hip Ratio,, Serum VLDL,S. LDL,S. Triglycerides,S. Total Cholesterol and an increase in Serum HDL. Reduction in percentage relief in subjective criteria of Medoroga. Statistical Analysis- by Z test and other tools as per requirement at the end of study period. |