A Clinical Trial to study the effects of Lekhana Basti (medicated Enema) and drug- Trayushnadya Loha in patients with Obesity

Phase 1/2

Not yet recruiting

• Conditions: Overweight,

• Registration Number: CTRI/2020/08/027026
• Lead Sponsor: Dr Ramesh Prasad Gupta

Brief Summary

Sthaulya is mentionedamong santarpanajanita vyadhi in Ayurvedic texts. In Sthaulyaetiological factors mainly vitiate meda-kapha and vata get avarita by excessiveMeda.Thus if we use only aptarpaka dravya, it increases thevitiated vata. Therefore, treatment should be planned considering vitiatedvata, meda and kapha.Panchakarma is the prime tool ofAyurvedic therapies, mainly considered as shodhana therapy. Acharya Charaka quotedthat there is a chance of recurrence of disease treated by Shamana therapy butShodhana therapy cures the disease from its root and there is no chance ofrecurrence.

***Lekhana basti***  is mentioned by different ayurvedic texts, for the treatment of SantarpanothaVyadhi, Kaphaja Roga and Kaphavrita Vata.The word ‘Lekhana’ itselfindicates its action that is *"Lekhanam Patlikaranam"*-scarifying helps in reduction of fat. Sharangadhara considered Lekhana in awide sense as *Deha Visoshanam*, ‘*Dhatun - Malan va DehsyaVishoshya Lekhayechha yat Lekhanam* i.e. the process of dryingup or desiccation of all excess Dosha, Dhatu and Mala. Basti denotes karma inwhich the drugs are administered through the anal canal and it stays for acertain period of time and then they draw the waste substances from all overthe body in to the colon and eliminate them out of the body by producingmovements in the colon resulting in to the pleasant effect.

Shodanain the form of Basti karma is mentioned as unique treatment modality inSthaulya specially with the drugs which are of ushna, tikshna, Lekhana thathelp in combating Kapha and medodushti. Lekhana Basti is emphasized by all theauthors of Ayurveda as treatment procedure in Medoroga. Considering thisaspect, Lekhana is opted for this study. Lekhana basti will be preparedin the same format of Asthapana Basti.

***Trayushnadyaloha*** is a popularly used oral medicine, mentioned in Yogaratnakaraas 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 Prayogaetc has been indicated. In the treatment of Sthaulya, the drug administrationfor the purpose of Karshana, should be Pragbhakta (before meal). Hence***TrayushnadyaLoha*** 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 withequal amount of Loha bhasma, that  haveushna virya and laghu, ruksha guna and are exactly opposite to the gunas ofkapha and medodhatu,  is planned toevaluate its therapeutic efficacy in sthaulya.

In spite of vigorous research workson this area with different modalities of the treatment, mankind is stillleading miserable life with this disease. It is the need of the hour to explorean effective, economic, domiciliary management for this disorder. Ayurveda emphasizesvarious treatment modalities in the treatment of Sthaulya roga that includesboth Shodhana and Shamana which are of Rukshana and Apatarpana in nature.  Thus consideringgravity 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 Bastiand TrayushnadyaLohain Sthaulya.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-12
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Remission- 100% relief in the signs and symptoms	Total Duration- 56 days
Marked Improvement- More than 75% relief in the signs and symptoms	Total Duration- 56 days
Moderate Improvement- 50-74% relief in the signs and symptoms	Total Duration- 56 days
Mild Improvement- 25-50% relief in signs and symptoms	Total Duration- 56 days

Trial Locations

Locations (1)

Gopa Bandhu Ayurveda Mahavidyalaya; 🇮🇳 Puri, ORISSA, India

Gopa Bandhu Ayurveda Mahavidyalaya

🇮🇳Puri, ORISSA, India

Prof Dr Sudarsan Behera

Principal investigator

9437199477

principalgampuri@gmail.com