CTRI Number |
CTRI/2025/06/089563 [Registered on: 25/06/2025] Trial Registered Prospectively |
Last Modified On: |
12/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
effect of haridradi basti in management of sthaulya |
Scientific Title of Study
|
Assessing the efficacy of haridradi basti in the management of sthaulya randomized controlled clinical trial |
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 Reshma Narendra Nale |
Designation |
MD Panchakarma Scholar |
Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 |
Address |
OPD No. 15 C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD No. 15 PANCHAKARMA DEPARTMENT Aurangabad MAHARASHTRA 431011 India |
Phone |
7888266593 |
Fax |
|
Email |
reshmanale2107@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Megha Raosaheb Survase |
Designation |
Associate Professor |
Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 |
Address |
OPD No. 15 C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD No. 15 PANCHAKARMA DEPARTMENT Aurangabad MAHARASHTRA 431011 India |
Phone |
8149888802 |
Fax |
|
Email |
drmegha26@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Reshma Narendra Nale |
Designation |
MD Panchakarma Scholar |
Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 |
Address |
OPD No. 15 C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD No. 15 PANCHAKARMA DEPARTMENT Aurangabad MAHARASHTRA 431011 India |
Phone |
7888266593 |
Fax |
|
Email |
reshmanale2107@gmail.com |
|
Source of Monetary or Material Support
|
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad, Maharashtra, India-431011 |
|
Primary Sponsor
|
Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad |
Address |
Panchakarma Department,CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad 431011 |
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 Reshma Nale |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad |
OPD NO.15 OF Panchakarma Department Aurangabad MAHARASHTRA |
7888266593
reshmanale2107@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak samhita, Procedure details: Haridradi Basti of 960 ml quantity in alternating sequence (vyatyasat krama) for duration of 8 days)
| 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sushruta sanhita , Procedure details: Triphala Basti of 480ml quantity in alternating sequence (vyatyasat krama) for duration of 8 days )
|
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Diagnosis of patient according sign and symptoms like Daurbalyam, Swedobadha, Kshudha atimatra, Daurgandhyam . Having BMI between 25.0 to 29.9 kg/m². Age between 18.0 to 60.0 years, irrespective of gender, irrespective of occupation and socio-economic status. |
|
ExclusionCriteria |
Details |
If patient age less than 18.0 years and greater than 60.0 years .
Having BMI greater than and equal to 30.0 kg/m².
Pregnant and lactating mother.
Patient having uncontrollable DM, HTN, Anorectal disorder,Systemic disorder. |
|
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 |
Reduce BMI in kg/m²
Reduce abdominal Girth |
Baseline 0th day, 8th day, 24th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Actively do day to day activity |
Baseline 0th day, 8th day, 24th day |
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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)
|
06/07/2025 |
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="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
|
Lifestyle is considered to be an important part of health, but in today’s sedentary lifestyles, lack of physical activities, stressful life, irregular diet, irregular sleeping pattern lead to different kind of lifestyle disorder. In today’s fast placed world Sthaulya has become a prevalent health issue affecting many due to lifestyle factors. Charaka samhita also described eight kinds of men who are undesirable nature in respect of their body (Physique). They are called Ashtonindatiyapurusha. One of them is "Ati-Sthula". A person having heaviness and bulkiness of body due to extreme growth especially in udarvadi region is termed as "Sthula" and state of Sthula is called as "Sthaulya". In Ayurveda Sthaulya is one of predominant disease of kapha, involving kapha, meda as a dosha and dushya in pathogenesis. Sthaulya is a bahudosha condition caused by derangement of agni in general and medodhatvaagni in particular. This leads to excessive production and accumulation of medodhatu thus obstructs the flow of vata. In Ayurveda Sthaulya is considered under santharpanajanya, medopradoshaja vikara as well as kapha Pradhana vikara, where apatarpana treatment modalities like langhna, ushna, tikshna are indicated. Sthaulya being agnivaishamya and vatadushti so that bastikarma is considered to best treatment. Acharya Sushrut, lekhan basti which is one of the type of nirhua basti containing drugs like makshika, gomutra, kshara and Haridradi dravya which medohara and lekshana property. According to Acharya Charaka Sthaulya chikitsa ruksha, ushna and tikshna. Haridradi basti dravya having property is ushna, tikshna, lekshniya and karshna reduced kapha and vata dosha and medodhatu.
Hypothesis Null Hypothesis: Haridradi basti is not effective in the management of Sthaulya.
Alternative Hypothesis: Haridradi basti is effective in the management of Sthaulya.
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