| CTRI Number |
CTRI/2025/04/085656 [Registered on: 25/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of Tryushanadi Sattu along with Mustadi Apatarpan Kwatha in patients of Sthaulya (Obesity) |
|
Scientific Title of Study
|
A Randomized clinical study to evaluate the efficacy of Tryushanadi Sattu and Mustadi Apatarpan Kwatha in management of Sthaulya w.s.r.to Obesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh Ashokrao Patil |
| Designation |
MD SCHOLAR |
| Affiliation |
R A Podar Medical (Ayu) College Worli,Mumbaii |
| Address |
Kayachikitsa OPD NO 18,M A Podar Ayurvedic Hospital,Dr Annie Basent Road, Worli Mumbai 400018 Maharashtra.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9923978555 |
| Fax |
|
| Email |
drmaheshapatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Arati Datye |
| Designation |
MD Kayachikitsa Assistant Professor Kayachikitsa |
| Affiliation |
R A Podar Medical (Ayu) College Worli,Mumbaii |
| Address |
Kayachikitsa OPD NO 18,M A Podar Ayurvedic Hospital,Dr Annie Basent Road, Worli Mumbai 400018 Maharashtra.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7758977066 |
| Fax |
|
| Email |
aratidatye@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahesh Ashokrao Patil |
| Designation |
MD SCHOLAR |
| Affiliation |
R A Podar Medical (Ayu) College Worli,Mumbaii |
| Address |
Kayachikitsa OPD NO 18,M A Podar Ayurvedic Hospital,Dr Annie Basent Road, Worli Mumbai 400018 Maharashtra.
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9923978555 |
| Fax |
|
| Email |
drmaheshapatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| M A Podar Ayurvedic Hospital,R A Podar Medical (Ayu)College, Worli Mumbai |
|
|
Primary Sponsor
|
| Name |
R A Podar Medical (Ayu) College Worli,Mumbaii |
| Address |
Dr Annie Basent Road Worli Mumbai 400018 |
| 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 |
| Dr Mahesh Ashokrao Patil |
M A Podar Hospital (Ayu) Worli Mumbai |
OPD NO 18 Department of Kayachikitsa, Dr Annie Basent Road Worli Mumbai 400018
Mumbai
MAHARASHTRA |
9923978555
drmaheshapatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of institution R A Podar Medical (Ayu) College Worli,Mumbaii |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z683||Body mass index (BMI) 30-39, adult. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tryushanadi Sattu, Reference: Charak Samhita sutrasthan, Route: Oral, Dosage Form: Sattu, Dose: 60(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadi Apatarpan Kwatha, Reference: Charak Samhita Sutrasthan, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having sign and symptoms of sthaulya Kshudra Shwas, Kshudhatimatra, Pipasadhikya,
Swedadhikya, Atinidra,Daurgandhya, Daurbalya.
b. Patient between age group 20-50 yrs, irrespective of gender
c.Patients with BMI More than 25 but less than 39 |
|
| ExclusionCriteria |
| Details |
1)Patients is known case of cardiac, pulmonary renal and hepatic diseases, etc.
2) Patients having medical emergencies associated with like Coronary Heart disease,
Atherosclerosis, Myocardial infarction etc.
3) Pregnant females and lactating women’s.
4) Patients having history of diabetic mellitus, thyroid disorder and HTN, and other endocrine
disease.
5) Overweight due to drug eg. -corticosteroids.
6) Patients is suffering from peptic ulcer disorder, bledding disorder were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
There is reduction in weight and bmi and anthropometry I.e. objective criteria and too the sign and symptoms of sthaulya (obesity)
|
6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the effect of Tryshanadi saktu in the signs and symptoms of sthaulya like kshudhadhikya
Nidradhikya,Swedadhikya, Daurbalya, Trushnadhikya etc. before and after treatment.
2. To Evaluate the effect of Tryshanadi saktu on weight, BMI.
3. To evaluate the effect of Tryshanadi saktu in the anthrometric measure.
4. To evaluate the effect of Tryshanadi saktu on Lipid Profile.
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/05/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In modern era of globaliization, India is currently witnessing rising number of people who are obese .Many among the Indian population have started relying on processed food that contain a huge percentage of trans-fat, sugar and other unhealthy and artificial ingredients. Sthaulya is one such lifestyle disorders Sedentary lifestyles are leading people to silent self-destruction, making one in every five Indian men and women obese. It has reached epidemic properties globally. 39% of adults in the world are overweight. Sthaulya is included under eight undesirable conditions (Ashtau Nindita), Shleshm Nanatmaj, Samtarpana Nimittaja Atinindita,Ati Brihmana Nimitaja and Bahu Dosha Janita Vikara. Moreover, Sushruta has emphasized on metabolic disturbances (Dhatvagnimandya) in the etiopathogenesis of Sthaulya. The patient of Sthaulya exhibits very strange phenomenon. Their appetite is excessive and whatever they eat is quickly digested, which indicates hyperfunctioning of the Jatharaagni. Besides this, the patient suffers from laziness, may be due to under supply of energy, which may be due to hypofunctioning of Bhutaagni. Further Dhatvagni also seems to be disturbed, as in Sthaulya patient mainly Medo-Dhatu is formed and there is deficiency of other Dhatu.Hence, it can be inferred that in Sthaulya, Jatharagni is Tikshna, Bhutagni is Manda and Dhatvagni is disturbed in their respective functions. On the basis of the above-mentioned facts of pathogenesis of Sthaulya, it can be said that the drug, which decreases Jatharagni particularly Abhyavahrana Shakti, increases Bhutagni and corrects the functions of Dhatvagni and at the same time have Medo-hara, Kapha-hara and Vatahara actions, may be suitable for its management. Therefore Today it is need to find the drug which is cost effective, easily available everywhere and easy to follow one such preparation is Tryushanadi sattu mention in charak samhita having properties like kaphagna, medohara. Probable mode of action in Sthaulya is caused by excessive use or practice of Kapha Vardhaka Ahara and Vihara mentioned as Santarpaka Nidana like, Ati-Guru, Ati-Snigdha, Ati-Pichchhil, Atishita, Navanna-pana, Ati-nidra, Ati-aasana, Avyayama etc. These Nidanas vitiate Rasa Dhatvagni, Meda Dhatvagni, Kapha Dosha and Vata Dosha. Trikatu Churna has Ushna, Laghu, Ruksha Guna and Deepana, Kapha-vata Hara and Shaulyahara Karma expected to increase the power of Rasa and Meda Dhatvagni, decrease in Kapha and Vata and thus decrease in further formation of Aaama Meda Dhatu and its deposition in body results in an improvement in Sthaulya. Hence this topic is been selected The study is divided into two arm interventional with Tryushanadi sattu and Mustadi Apatarpan kwatha . Randomizationis done by using computer software. 35 patients of each interventional and comparator selected. patients with signed consent are going to evaluate efficacy of Tryushanadi sattu and Mustadi Apatarpan Kwatha in management of sthaulya (Obesity) Acceessment will be done on the basis of Subjesctive and Objective Parameters.
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