“An study to evaluate the efficacy of virechana(purgation) and basti (enema) followed by vishwadi dwadashanga kwatha (decoction) in the management of fibromyalgiaâ€.
- Conditions
- Other specified disorders of muscle. Ayurveda Condition: MAMSAGATAVATAKOPA,
- Registration Number
- CTRI/2022/05/042676
- Lead Sponsor
- National Institute of Ayurveda
- Brief Summary
Fibromyalgiasyndrome (FMS) is defined as a chronic pain syndrome with a complex,multifactorial and not completely known etiopathogenesis and an increasedfrequency among women.It is characterized by generalized musculoskeletalpain and palpation specific tender points on physical examination oftenaccompanied by associated symptoms such as sleep disorders, fatigue, somaticand cognitive symptoms, as well as psychic disorders.The first ever description of the disease multiple andwidespread pain in muscles ultimately fatiguein Ayurveda text was mentionedas *Mamsagata Vata*. The specificdisease condition associated with ‘*Gurvang,atyarth todanvat vedana, Dandmushtihatam vedana, tatha atyarth sharmita*- (Multiple and widespread pain in musclesultimately fatigue, palpationspecific tender points accompanied with associate symptom such as sleepdisorders, somatic and cognitive symptoms as well as psychic disorders). The textual line of treatment of *Vatavyadhi* is followedin the treatment of *Mamsagata Vata* which states *Virechana*, *NiruhaBasti* and*Shaman Chikitsa.*In this work *Virechana,Rasnadi Basti and Vishwadi Dwadashanga Kwatha* are purposedas an adjuvant therapy in themanagement of *Mamsagata Vata* withspecial reference to Fibromyalgia.
WORK PLAN:**GROUPING**
Patients will berandomly divided into two groups (15 patients in each group) detail as below-
**GroupA** –*Virechana Karma* followed by *Viswadi Dwadashanga Kwatha.*
**GroupB** –*Rasnadi Basti* followed by *Viswadi Dwadashanga Kwatha*
Route and method of application–1. *Virechana* will be conducted as per standardprotocol and *Virechana Yoga* will be givenaccording to *Koshtha* on empty stomachat 9-10 am.
2. *Rasnadi Basti* in *Kala Basti Krama* (for 16 days)through anal route.
3. *ViswadiDwadashanga Kwatha* as *ShamanaChikitsa* for 15 days.
**Time of administration of *Virechana Karma –*** Latemorning, once (As per SOP of P.K. Dept. NIA Jaipur).
**Route and method of administration of *Virechana Karma*** –
*1.**Snehpana*–It will be done by *Go*-*Grhita* for 3days*.*
2. *SarvangaAbhyanga* (with *Dashmoola taila*)*Sarvanga Swedana* (with *Dashmoola Kwatha*) for continue 4 days.
3. *Virechana* will be conducted as per standardprotocol and *Virechana Yoga* will be giventhrough Oral route according to *Koshtha* onempty stomach at 9-10 am.
*4.* *Sansarjana Krama* - According to *Shuddhi*
**Method of administration of *Viswadi Dwadashanga Kwatha-*** Oral route
**Dosage for *Viswadi Dwadashanga Kwatha*** – 20 gmB.D. (Morning and Evening) Before Meal.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
- 1.Patients between 18 and 65 years of age.
- 2.Patients with the clinical features of Mamsagata Vata.
- 3.Patients with the clinical features of Fibromyalgia.
- 4.Patients fit for Virechana Karma and Niruha Basti.
- 5.Chronicity less than 10 years.
- 1.Patient, suffering from any chronic debilitating disease like T.B., Varicose vein, Asthma, Rheumatoid Arthritis & other chronic problems etc.
- and having other serious pathology.
- 2.Patients suffering from systemic disorders as cardiac problem, uncontrolled Diabetes Mellitus, Uncontrolled Hypertension, Paralysis, Malignancy, HIV, HBsAg, Leprosy.
- 3.Pregnant women and lactating mother.
- 4.Associated with simple or compound fractures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in American College of Rheumatology (ACR): Preliminary Criteria for Fibromyalgia assessment will be done on 0thday, 16th day, 31st day.
- Secondary Outcome Measures
Name Time Method 1. Changes in FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ). 2.VAS-SCALE.: VAS have been recommended: no pain (0–4 mm), mild pain (5-44 mm),
Trial Locations
- Locations (1)
National Institute of Ayurveda
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda🇮🇳Jaipur, RAJASTHAN, IndiaShalu Rani SinghalPrincipal investigator6378766221shalusinghal147@gmail.com