| CTRI Number |
CTRI/2025/03/083564 [Registered on: 27/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to observe the effect of mustadikwath ghanwati with patol yush and mustadikwath ghanwati alone in treating obesity .
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Scientific Title of Study
|
A randomised clinical study to evaluate add on effect of patol yush as an aahariya kalpana over mustadikwath ghanwati in the management of sthaulya with special reference to obesity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shivani Bapusaheb Jasud |
| Designation |
M.D. (First year), Swasthavritta |
| Affiliation |
R. A. Podar Medical (Ayu.) College, Worli, 400018 |
| Address |
Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, Mumbai-400018, Maharashtra
Mumbai MAHARASHTRA 400018 India |
| Phone |
9284733108 |
| Fax |
|
| Email |
shivanijasud7@gmail.com |
|
Details of Contact Person Scientific Query
Modification(s)
|
| Name |
Dr. Vrushali Khandekar |
| Designation |
Associate professor |
| Affiliation |
R. A. Podar Medical (Ayu.) College, Worli, 400018 |
| Address |
Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, Mumbai-400018, Maharashtra
Mumbai MAHARASHTRA 400018 India |
| Phone |
7588654776 |
| Fax |
|
| Email |
ujedevrushali@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Shivani Bapusaheb Jasud |
| Designation |
M.D. (First year), Swasthavritta |
| Affiliation |
R. A. Podar Medical (Ayu.) College, Worli, 400018 |
| Address |
Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, Mumbai-400018, Maharashtra
Mumbai MAHARASHTRA 400018 India |
| Phone |
9284733108 |
| Fax |
|
| Email |
shivanijasud7@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Shivani Bapusaheb Jassud |
| Address |
Department of Swasthavritta, R. A. Podar Medical (Ayu.) College, Worli, 400018 |
| Type of Sponsor |
Other [Self] |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivani Bapusaheb Jasud |
M. A. Podar Ayurvedic Hospital, Worli, Mumbai 400018 |
OPD no.16, Swasthyarakshan OPD, Swasthavritta Department, M. A. Podar Ayurvedic Hospital, Dr. Annie Besant Road, Worli, Mumbai 400018 Mumbai MAHARASHTRA |
9284733108
shivanijasud7@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patol Yush, Reference: Sushrutsamhita Sutrasthan 46/371, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 135(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadikwath Ghanwati, Reference: Charaka Samhita Sutrasthan 23/12-14, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18 to 50 years irrespective of gender, caste and religion.
2.BMI 25 to 39.9kg per meter square
3.Subjects showing classical signs and symptoms of Sthaulya like Dourbalya, Swedaatipravruti, Dourghandhya, Nidraadhikya, Kshudhaadhiikya and Pipasa adhikya.
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| ExclusionCriteria |
| Details |
1.Pregnant women
2.Lactating mother
3.Subjects with long term steroid treatment.
4.Subjects having comorbidities like DM, cardiovascular diseases, cancers etc.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess the add on effect of patol yush over mustadikwath ghanawati in sthoulya with special reference to obesity. |
5 weeks
Follow up every week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To observe the add on effect of patol yush over mustadikwath ghanwati on BMI, waist hip ratio over period of 5 weeks.
2.To observe the add on effect of patol yush over mustadikwath ghanwati on lipid profile over period of 5 weeks. |
5 weeks
Follow up every week |
|
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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)
|
07/04/2025 |
| 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="2" Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The main aim of Ayurveda is to cure
diseases and maintain a state of health. Ayurveda focuses on maintaining and
restoring the body’s ability to balance itself and fight ailments. Obesity is a
chronic, complex disease defined by excessive fat deposits that can impair
health. It increases the risk of type 2 diabetes, heart disease, and can affect
bone health, reproduction, and the risk of certain cancers. Obesity also
impacts the quality of life, including sleep and movement.
Overweight and obesity are the
fifth leading cause of global deaths. According to the World Health
Organization (WHO) in 2022, 2.5 billion adults aged 18 years and older were
overweight, including over 890 million adults living with obesity. The prevalence
of Sthaulya (obesity) is increasing worldwide across all age groups.
According to Ayurvedic texts, Sthaulya is a Santarpanjanya Vyadhi
and is detailed in the Ashtang Hridaya and Charak Samhita. In
obesity, the Medovaha Strotas (fat channels) are affected, leading to
the overgrowth of Medodhatu (fat tissue), which ultimately manifests as
obesity.
Weight gain occurs due to an
imbalance between energy intake and energy expenditure. According to Acharya
Charaka, continuous intake of causative factors aggravates Kaphadosha
and Medodhatu due to their similar properties. This increases the
obstruction of Meda in the channels, and as a result, Vata in the
digestive system becomes hyperactive. This stimulates Agni (digestive
fire), causing rapid digestion of food and leading to frequent hunger. If
sufficient food is not available, this imbalance can cause severe
complications.
Ayurveda emphasizes the
importance of proper nutrition through appropriate food choices, combinations,
and cooking methods. Medohara and Kaphanashana diets are
recommended in Ayurveda for managing Sthaulya (obesity). Patol Yush
is mentioned in the Sushrut Samhita as an effective remedy for treating Medoroga
(obesity). It possesses properties such as reducing Kapha, eliminating
excess fat, improving digestion, and supporting heart health. This study aims
to evaluate the combined effect of Patol Yush as an Aahariya Kalpana
(dietary formulation) with Mustadikwath Ghanwati in managing Sthaulya,
as Mustadikwath Ghanwati has already shown effectiveness in treating
obesity.
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