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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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