An Open Labelled RCT study to Assess the efficacy of Ayugma Takrabasti, Agnisunurasa over Bhunimbadi churna in Grahani roga(Irritable Bowel Syndrome -D )

Irritable bowel syndrome1 (IBS-D) is a Gastrointestinal disorder having a group of symptoms including abdominal pain and changes in the pattern of bowel movements without any evidence of underlying damage. The pathogenesis of IBS is not fully understood, although roles for abnormal gut motor and sensory activity, central neural dysfunction, psychological disturbances, stress, and luminal factors have been proposed2. It is estimated that the prevalence of IBS in India ranges from 0.4 to 4.2%3 and has a significant impact on the quality of life and social functioning of patients and with female predominance

The cause of IBS is likely to be multifactorial. Patients often show evidence of visceral hypersensitivity and motility abnormalities. Many IBS patients have increased anxiety and their symptoms are often exacerbated by mental or physical stress suggesting abnormal brain–gut interaction. Genetic studies suggest a few IBS patients may have genetic abnormalities affecting the serotonin transport system in the enteric nerves. Up to 30% of IBS patients may have bile acid malabsorption. Gut dysbiosis and impaired mucosa permeability also been reported in many IBS patients. This may lead to subclinical mucosa inflammation. Severity of symptoms varies and can significantly impair quality of life, resulting in high health care costs.

Grahani Roga(IBS-D) mentioned in Ayurvedic texts simulates with  Irritable bowel syndrome in Western Science. In Grahani(IBS-D), digestion of food do not occur properly due to dusti of Jataragni which leads to formation of ‘Ama’. It disturbs the normal flora of GI tract. The research question here is whether Gut dysbiosis and impaired mucosa permeability can be treated with Takrabasti followed by Shamana aushadi which are Grahi, Stambaka, Anti-microbial and Anti-oxidant will be effective in improving IBS-D.

Takraprayoga in Grahani(IBS-D) is highlighted as the best Aushadhi in all the brahatrayee, which possess Deepana, Grahi & Laghu gunas4. Charaka Samhita explains Takra as basti dravya under Amlaskanda which is one among Shadasthapanaskanda5. Sushruta Samhita mentioned Takra as avapa dravya in Grahi basti6. Hence Takra is given as Basti dravya in both group for  management of Grahani(IBS-D). It acts at enteric nervous system and influences cellular level and stimulate Hypothalamic Pitutary Thyroid axis by virtue of thyroid gut connection

Basti eliminates vitiated Vata, Pitta and Kapha from the body, it helps in decreasing Dravatva of Pitta and Guruta of Kapha. Hence Prithvi and Apya bhutas gets decreased with eventual elevation of Agneya tatva in this way it may help in potentiating Agni.

Basti helps to convert dysbiotic state of intestinal flora in symbiotic state so  Takrabasti is considered for this Intervention.

Bhunimbadi churna7 contains Bhunimba, Katuki, Shunti, Pippali, Maricha, Musta ,Indrayava , Chitraka ,Vatsaka having anti-bacterial, anti-microbial, anti-spasmodic and anti-diarrheal properties and are kapha vatahara which acts on Grahani roga(IBS-D) , Pandu , Aruchi and Atisara.

Agnisunurasa8 contains Kapardika Bhasma, Shanka Bhasma , Parada, Gandhaka  and Maricha which are effective in Grahani(IBS-D),shosha, Gulma, Pandu, Arshas.

Hence to assess the efficacy of Takrabasti and Agnisunu rasa in one arm and Takrabasti and Bhunimba churna in another arm as a control group, with an alternative hypothesis the present study entitled

“AN OPEN LABELLED RCT STUDY TO ASSESS THE EFFICACY OF AYUGMA TAKRABASTI, AGNISUNURASA OVER BHUNIMBADI CHURNA IN  GRAHANI ROGA (IRRITABLE BOWEL SYNDROME-D)” Is UNDERTAKEN.

OBJECTIVES OF THE STUDY:

· To assess the efficacy of  Ayugma Takra basti followed by Agnisunurasa in Grahani Roga(IBS-D).

· To assess the efficacy of  Ayugma Takra basti followed by Bhunimbadi churna in Grahani Roga(IBS-D).

To compare the efficacy of Ayugma Takra basti , Agnisunurasa over Bhunimbadi churna in Grahani roga(IBS-D).

A) Diagnostic Criteria:

The patients will be diagnosed based on-

· ROME IV Diagnostic Criteria :

Recurrent abdominal pain on average, at least 1 day per week in last 3 months, associated with > two of following criteria

1. Related to defecation

2. Associated with a change in frequency of stool

3. Associated with a change in form of stool

· Blood routine: HB%, ESR, TLC, DLC, CRP

· Colonoscopy to ascess changes for irritated tissues, polyps in large intestine & rectum in required patients.

 B) Inclusion Criteria:

· Subjects complaining of Muhurdravamala pravritti, Muhurmuhurmala pravritti, lakshanas of Grahani Roga(IBS-D) i.e Abdominal pain, flatulence and bloating  present for at least 3 Months will be  selected.

· Subjects who are freshly diagnosed or diagnosed case of IBS-D/Grahani.

· Subjects between age group of 20-70yrs.

· Subjects irrespective of sex, religion, occupation and chronicity.

· Subjects who will  sign for  informed consent form.

 C) Exclusion Criteria:

· Patients suffering with Upadravas of Grahani(IBS-D) will be excluded.

· Patients with major ailments like Heart disease, Ascites etc .

· Also the Patients suffering from severe systemic disorders which interferes with course of intervention will be excluded.

· Those who are not fit for Takra Basti karma.

· Lactating and pregnant women**.**

STUDY DESIGN

Study type

Prospective, Open labelled ,RCT study, Add on

|Estimated enrolment

30 subjects (15 in each group)

|Intervention model

 Comparative

|Allocation

Randomization

INTERVENTION

Group A

Takrabasti followed by Agnisunurasa

|Group B

Takrabasti followed by Bhunimbadi churna

|Masking

OPEN

|Primary purpose

Treatment

STUDY

DURATION

Treatment duration

40 days

|Follow up

07 days

|Total duration

47 days

GRADINGS ARE GIVEN AS FOLLOWS

MUHURDRAVA MALA PRAVRITI

SEVERITY

GRADE

|Passing of normal consistency stool

0

|Passing stool (2-3 times/day)irregular, without pain

1

|Passing stool (3-5 times/day)just after meals,irregular with pain

2

|Passing stools more than 5 times/day just after meals,irregular with pain

3

AGNIMANDYA

SEVERITY

GRADE

|Normal appetite

0

|Loss of appetite without eating habits

1

|Oral intake altered without significant weight loss

2

|Associated with significant weight loss

3

UDARASHOOLA (ABDOMINAL PAIN OR DISCOMFORT)

SEVERITY

GRADE

|No abdominal pain

0

|Sometime/rarely  abdominal pain

1

|Intermittent crampy lower abdominal pain which is relieved by passage of flatus or stool

2

|Continuous abdominal pain often over the right upper quadrant/ mid epigastria/ lower iliac region which is not relieved by passage of flatus or stool.

3

SHLESHMA MALA PRAVRITI (PRESENCE OF MUCOUS IN STOOL)

SEVERITY

GRADE

|No visible mucous in stool

0

|Visible mucous stickled to the stool

1

|Passage of mucous with frequent stool

2

|Passage of large amount of mucous in stool

3

Objective Parameters:

1. Body weight

2. CBC (Complete blood profile)

3. C-Reactive protein

4. ESR

5. ROME IV DIAGNOSTIC CRITERIA

SUBJECTIVE DATA WILL BE COLLECTED AS FOLLOWS:

1. On 0th day     –  before treatment

2. On 13th day  -   after Takrabasti treatment

3. On  40th day  -  after course of Shamana aushadi

4. On  47th day   - after follow up