| CTRI Number |
CTRI/2024/10/075941 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To assess the effect of Badishep in Constipation in the age group of 20-50 years. |
|
Scientific Title of Study
|
An exploratory clinical trial to assess the efficacy of Mishreya(Foeniculum vulgare Mill.)in Malavibandha in the age group of 20-50 years. |
| 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 Poonam Yadav |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, 1st floor, Swasthavritta and Yoga department, Sector no 25, Pradhikran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9527206872 |
| Fax |
|
| Email |
poonamy498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajkumar Bobade |
| Designation |
HOD |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, 1st floor, Swasthavritta and Yoga department, Sector no 25, Pradhikran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9403928005 |
| Fax |
|
| Email |
rajkumarbobade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Yadav |
| Designation |
PG Student |
| Affiliation |
PDEAs College of Ayurved and Research Centre, Nigdi, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, 1st floor, Swasthavritta and Yoga department, Sector no 25, Pradhikran, Nigdi, Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9527206872 |
| Fax |
|
| Email |
poonamy498@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Nigdi, Pune 411044 Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
Sector no 25 Pradhikran Nigdi Pune 411044 |
| Type of Sponsor |
Private 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 Poonam Yadav |
Ayurved Rugnalaya and Sterling Multispecialty Hospital Nigdi Pune |
Ayurved Rugnalaya And Sterling Multispecialty Hospital Swasthavritta department OPD No 123 B Nigdi Pune
Pune
MAHARASHTRA |
9527206872
poonamy498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Standard Operating Procedure for Institutional Ethical Committee-I for Human Research at Pune District Education Associations College of Ayurved and Research Centre Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Volunteers of age group 20-50 years having Malavibandha lakshana due to lifestyle factors. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mishreya(Foeniculum vulgare Mill.), Reference: Bhavprakash Nighantu, Haritakyadi Varga, Shloka No-91-92, Route: Oral, Dosage Form: , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: Mishreya(Foeniculum vulgare Mill.)10 gm per day is given orally before meal for one month. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Volunteers of age group 20 to 50 years with Malavibandha lakshana for less than 1 month. |
|
| ExclusionCriteria |
| Details |
1. Volunteers with chronic illness and malignant disease.
2. Volunteers having Malavibandha as a result of disease like Grahini,Arsh,Parikartika.
3. In pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Mishreya given before meal for 1 month in Malavibandha in the age group of 20 to 50 years. |
Three times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/12/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Malavibandha is a symptom caused due to improper dietary habits, lack of exercise and disturbed sleeping pattern leading to apanavayu dushti. While considering all the above lifestyle factors, there is need of anulomaka, deepana and pachana dravya in Malavibandha. Mishreya being Katu, Tikta in nature, Madhur in vipaka and ushna in nature stimulates agni which in turn digests metabolic waste and ease the process of digestion. Mishreya is deepana and vataanulomaka and maintain pachaka agni,apana vayu in the body. As per Bhavprakash Nighantu Mishreya helps in relieving Malavibandha. So this is an attempt to estimate the effect of Mishreya in Malavibandha. |