CTRI Number |
CTRI/2020/08/027026 [Registered on: 07/08/2020] Trial Registered Prospectively |
Last Modified On: |
24/07/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Diagnostic |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A Clinical Trial to study the effects of Lekhana Basti (medicated Enema) and drug- Trayushnadya Loha in patients with Obesity |
Scientific Title of Study
|
A COMPARATIVE CLINICAL TRIAL EVALUATING THE THERAPEUTIC EFFECT OF LEKHANA BASTI AND TRAYUSHNADYA LOHA IN STHAULYA w.s.r. TO OBESITY |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
RAMESH PRASAD GUPTA |
Designation |
PhD Scholar |
Affiliation |
Gopa Bandhu Ayurveda Mahavidyalaya Puri Odisha |
Address |
Dr. Ramesh Prasad Gupta, Ph. D. Scholar, Dept. of Kayachikitsa, Gopabandhu Ayurveda Mahavidyalaya, Puri Postal Address- Flat No. 201, Shiva Residency Phase 2, Mathpurena, Raipur (Chhattisgarh)- 492001 Raipur CHHATTISGARH 492001 India |
Phone |
09977363432 |
Fax |
|
Email |
drrameshgupta85@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr Bipin Bihari Khutia |
Designation |
Principal |
Affiliation |
Kriya Sharir Department |
Address |
Principal Office Kaviraj Ananta Tripathy Sharma Ayurveda College And Hospital (Berhampur University)
Ankushpur Ganjam ORISSA 761100 India |
Phone |
9437499423 |
Fax |
|
Email |
bbkhuntia69@gmail.com |
|
Details of Contact Person Public Query
|
Name |
RAMESH PRASAD GUPTA |
Designation |
PhD Scholar |
Affiliation |
Gopa Bandhu Ayurveda Mahavidyalaya Puri Odisha |
Address |
Dr. Ramesh Prasad Gupta, Ph. D. Scholar, Dept. of Kayachikitsa, Gopabandhu Ayurveda Mahavidyalaya, Puri Postal Address- Flat No. 201, Shiva Residency Phase 2, Mathpurena, Raipur (Chhattisgarh)- 492001
CHHATTISGARH 492001 India |
Phone |
09977363432 |
Fax |
|
Email |
drrameshgupta85@gmail.com |
|
Source of Monetary or Material Support
|
Department Of Kayachikitsa,
Hospital- Gopabandhu Ayurveda Mahavidyalaya V.I.P. Road Puri Odisha Pin- 752002 |
|
Primary Sponsor
|
Name |
Dr Ramesh Prasad Gupta |
Address |
Flat No. 201, Shiva Residency Phase 2, Mathpurena, Raipur (C.G.) 492001 |
Type of Sponsor |
Other [Ph D Research Scholar] |
|
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 Sudarsan Behera |
Gopa Bandhu Ayurveda Mahavidyalaya |
VIP Road Puri Odisha 752002 Puri ORISSA |
9437199477
principalgampuri@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Clearance Committee- Human Gopa Bandhu Ayurveda Mahavidyalaya Puri |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Lekhana Basti, Trayushnadya Loha Vati, Lekhana Basti and Trayushnadya Loha Vati |
Group I- Intervention: Lekhana Basti, Duration 24 days (8 +16), Follow up on Day- 42 & Day- 56,Total duration 56 days/8 weeks;
Group II – Intervention: Trayushnadya Loha 2 Vati of 500mg twice a Day, before food for 24 days, Follow up on Day- 42 & Day- 56, Total duration 56 days/8 weeks;
Group III- Intervention: Lekhana Basti and Trayushnadya Loha (2 Vati of 500mg twice a Day, before food) for 24 days, Follow up on Day- 42 & Day- 56, Total duration 56 days/8 weeks. |
Comparator Agent |
Not applicable |
Not applicable |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients with classical features of Sthaulya.
Patients having BMI more than or equal to 30 kg/m2
Patients of either gender between the groups of 20-60 years.
Patients fit for Basti karma.
|
|
ExclusionCriteria |
Details |
Patients not fulfilling the inclusion criteria.
Patients having associated complication like cardiac diseases.
Patients having Sthaulya due to endocrine or genetic abnormalities
Patients having fissure, fistula and hemorrhoids.
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Complete Remission- 100% relief in the signs and symptoms
Marked Improvement- More than 75% relief in the signs and symptoms
Moderate Improvement- 50-74% relief in the signs and symptoms
Mild Improvement- 25-50% relief in signs and symptoms |
Total Duration- 56 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
NONE |
NIL |
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
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 1/ Phase 2 |
Date of First Enrollment (India)
|
01/12/2020 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
To be published in 2021 |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Sthaulya is mentioned
among santarpanajanita vyadhi in Ayurvedic texts. In Sthaulya
etiological factors mainly vitiate meda-kapha and vata get avarita by excessive
Meda. Thus if we use only aptarpaka dravya, it increases the
vitiated vata. Therefore, treatment should be planned considering vitiated
vata, meda and kapha. Panchakarma is the prime tool of
Ayurvedic therapies, mainly considered as shodhana therapy. Acharya Charaka quoted
that there is a chance of recurrence of disease treated by Shamana therapy but
Shodhana therapy cures the disease from its root and there is no chance of
recurrence. Lekhana basti is mentioned by different ayurvedic texts, for the treatment of Santarpanotha
Vyadhi, Kaphaja Roga and Kaphavrita Vata. The word ‘Lekhana’ itself
indicates its action that is "Lekhanam Patlikaranam" -
scarifying helps in reduction of fat. Sharangadhara considered Lekhana in a
wide sense as Deha Visoshanam, ‘Dhatun - Malan va Dehsya
Vishoshya Lekhayechha yat Lekhanam i.e. the process of drying
up or desiccation of all excess Dosha, Dhatu and Mala. Basti denotes karma in
which the drugs are administered through the anal canal and it stays for a
certain period of time and then they draw the waste substances from all over
the body in to the colon and eliminate them out of the body by producing
movements in the colon resulting in to the pleasant effect.
Shodana
in the form of Basti karma is mentioned as unique treatment modality in
Sthaulya specially with the drugs which are of ushna, tikshna, Lekhana that
help in combating Kapha and medodushti. Lekhana Basti is emphasized by all the
authors of Ayurveda as treatment procedure in Medoroga. Considering this
aspect, Lekhana is opted for this study. Lekhana basti will be prepared
in the same format of Asthapana Basti.
Trayushnadya
loha is a popularly used oral medicine, mentioned in Yogaratnakara
as shamanoushadhi for Medoroga Chikitsa. The ideal shamana in the treatment of Sthaulya is usage of Vata,
kaphahara, and Medohara properties. Oral administration of various drugs like Shilajatu, Triphala, Guggulu Prayoga, Madhvambu Prayoga, Gomutra Prayoga
etc has been indicated. In the treatment of Sthaulya, the drug administration
for the purpose of Karshana, should be Pragbhakta (before meal). Hence
Trayushnadya
Loha the drug is with a combination of Aamalaki,
Vibheetaki, Hareetaki, Shunti, Pippali, Maricha, Chavya, Chitraka, Bakuchi,
Bida lavana, Audbhida lavana, Saindhava lavana and Souvarchala lavana with
equal amount of Loha bhasma, that have
ushna virya and laghu, ruksha guna and are exactly opposite to the gunas of
kapha and medodhatu, is planned to
evaluate its therapeutic efficacy in sthaulya.
In spite of vigorous research works
on this area with different modalities of the treatment, mankind is still
leading miserable life with this disease. It is the need of the hour to explore
an effective, economic, domiciliary management for this disorder. Ayurveda emphasizes
various treatment modalities in the treatment of Sthaulya roga that includes
both Shodhana and Shamana which are of Rukshana and Apatarpana in nature. Thus considering
gravity of the problem and availability of effective remedy this study entitled A COMPARATIVE CLINICAL TRIAL EVALUATING theTHERAPEUTIC effECT of LEKHANA BASTI AND TRAYUSHNADYA LOHA in sthaulya w.s.r. TO OBESITY is planned to evaluate and to compare the efficacy of Lekhana Basti
and Trayushnadya
Loha in Sthaulya. |