1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [drmenka.cbpacs@gmail.con].
   


6. For how long will this data be available start date provided 25-03-2025 and end date provided 20-10-2026?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

ANATOMICAL ASSESSMENT OF GUDA VALI IN RELATION TO PREVALENCE OF SHUSHKA AND ARDRA ARSHA- A CROSS-SECTIONAL SURVEY

1.    INTRODUCTION

In today’s modern era, the individual’s stressful life, sedentary habits, irregular sleep-wake pattern, irregular diet and unhealthy foods makes people more prone to the ano-rectal diseases such as fissure and hemorrhoids (Arsha).

Arsha is defined as “arivat pranan shrinoti hinasti iti arshah”. The disease which troubles a person’s vital force (prana) like enemy is termed as Arsha¹. This is mentioned in all classical text books of Ayurveda. This is a painful situation in terms of the difficulties and its management. The vitiated vayu, pitta, kapha etc. become dislodged from their natural seats in the body and carried down through large intestine in the descending colon and getting lodged there to give rise to growths of polyp which are known as piles. It is Dirghakalanubandhi, Dushchikitsya in nature, and Tridoshik and involves the Marma².

Acharya Sushrut and Acharya Vaghbhata described Arsha in the “Ashtha Mahagada”. In Ayurvedic literature various synonyms of Arsha are given eg. Durnamakam, Gudakila, Gudankur etc. The main characteristic feature of Arsha is sprouts like growth in the ano-rectum. The main complaints of arsha are bleeding, pain and prolapsed pile mass.

Symptoms of Arsha clinically resemble as Hemorrhoids also known as Piles in modern science. Their maximum concepts are similar to each other.

Hemorrhoids are the most common anorectal disease³, characterized by alteration in vasculature of the anal canal including blood vessels supporting tissues, muscles and elastic fibres⁴. There is a network of small veins within the inner lining of the anus and lower rectum⁵.

The estimated worldwide prevalence ranges from 2.9% to 27.9%, of which more than 4% are symptomatic^6,7. Age distribution demonstrates a Gaussian distribution with a peak incidence between 45 and 65 years with subsequent decline after 65 years^8,9. Men are more frequently affected than women¹⁰. The progressive pathogenesis of disease produces various symptoms in patients such as bleeding, prolapse, pruritis in anus, pain etc.

Guda starts from Sthulanthara, It is Mula of Purishavaha Srotas¹¹ and one amongst Sadyopranahara Tri Marmas (three vital injury points resulting immediate death). Total length of Guda is 4 ½ Angula.¹²

In the present days the people are very busy with work and running with time at the cost of their health, totally the people  are  neglecting  their  health.  Due to lack of Exercise,  sedentary   life,   consuming   unhealthy   and spicy  food.  This  unhealthy  food  Spoil  the Annavaha, Prushavaha Srotas and Guda Sthana.

The  people  who  are  in sitting  posture  for  long  time  and who do not keep clean the Guda Sthana. The Guda sthana Vali are affected and might lead to Guda rogas like Malabaddam, Parikartika, Arsha, Bhagandara,  Here the Samavarini Vali plays major role to expel the Apana Vayu and Purisha(Mala).

The Samavarini Vali is correlated as external sphincter, if this Sphincter injured the cut off processes was failed and  the  fecal  incontinence  will  occur,  that  was  an embracing to the patient and surrounding people also. Lot   of   Surgical   and   medical   importance   is   there regarding Samavarini Vali and Guda pradesha. Patients concealing anal symptoms are significant in general practice despite the impact on quality of life. Anal examination is seldom done. Improved training of general practitioners is required to break the taboo. So, there is big  need  to assess and understand the Arsha roga according to the different Guda Valis.

2.    LACUNAE IN EXISTING KNOWLEDGE

·       The work on Arsha and its management has been a part of research in the streamline of Shalya Tantra but seldom has been done to establish a relation between Guda Vali and Arsha. This study will help in establishing a relation between them.

·       In Rachana Sharir, only literary study has been done on the concept of Guda vali and seldom has been done on Clinical aspect. This study is aimed at applied aspect of Guda Vali.

3.    RESEARCH QUESTION

Is their any difference in prevalence of Shushka and Ardra Arsha in different Guda Vali?

4.    HYPOTHESIS

4.1 Null Hypothesis (H0)- There is no statistically significant difference in the prevalence of Shushka and Ardra Arsha in Guda Vali.

4.2 Alternate Hypothesis (HA) – There is statistically significant difference in the prevalence of Shushka and Ardra Arsha in Guda Vali.

5.    LITERATURE REVIEW OF GUDA

5.1 Utpatti of Guda

According to Sushruta, Guda is formed in embryonic stage by the most important Sara part of Rakta and Kapha is digested by Pita with the help of Vayu.¹³ Bhadrashaunaka mentions Guda develops first in the body.¹⁴ Sushruta has mentioned that a soft organ like Guda is formed by the maternal Source of the body.¹⁵ As per the embryology, the depression consisting of ectoderm, the proctoderm, forms in the hindgut and goes on to develop into the anus.¹⁶

5.2 Nirukti (Definition)

“Guda Kridayam Ta Gu Malotsarge” The word Guda derived from root “Gu” Which means Guda is the excretion of Mala.¹⁷ The opening of the anal canal to the exterior called the anus.

5.3 Sthana

Guda is attached to Annavaha Nalika after Sthoolantra. It is the last part in the Annavaha Nalika. The terminal 2-3 cm of the rectum is called the anal canal.

5.4 Angula Pramana

It is about 4½ Angula Pramana. It ends to exterior by Guda Marga. The last half Anguli portion of Guda is called as Gudaushta.

5.5 Avayavas

Guda is divided into 3 Valis, as Abhyantara, Madhya and Bahya situated at a distance of 1½ Anguli Pramana. Sushruta and Vagbhata described the presence of three Vali (fold or Curvatures) named Pravahini, Visarjani and Samvarini. All these Vali are situated One over another resembling the shape like curve of conch shell and color like palate of an elephant.¹⁸

5.6 Descriptions of Guda Valis

      I.         Pravahini

First Vali situated in the upper part of the Guda. Since it pushes the Mala downwards, it is called as Pravahini, which helps for the passing of Mala forward.

   II.         Visarjani

It is the second Vali,  situated  1½ Anguli below  the Pravahini Vali and 1½ Anguli above the Samvarini Vali which expands Guda and helps in expulsion of Mala.

 III.         Samvarini

This is being the 3^rd and last Vali situated 1½ Anguli above the Guda oushta which  helps  for  closure  of  the Guda.

5.7 Guda Marma

Guda is located in the Madhya Shareera, in the trunk region. It is in continuity with Sthula Antra (Large Intestine). Like the large intestine, Guda is also a site of Apana Vata.¹⁹ Injury to Guda Marma is said to take away the life immediately.

5.8 Categories in which the Guda Marma is included

1. Madhya Shareera Gata Marma, Udara Gata Marma (Madhya Shareera = present in the middle portion of the body, trunk, Udara = abdomen).

2. Mamsa Marma - It is predominantly made up of Mamsa i.e., muscle tissue. The other elements namely Sira (blood vessels), Asthi (bone), Sandhi (joints) and Snayu (ligaments, tendons, nerves) are also present but in a lesser proportion.

3. Dhamni Marma - According to Acharya Vagbhata It is predominantly made up of Dhamni i.e., blood vessels.

4. Sadhyo Praanahara Marma - (Sadhyo - Immediate, Pranahara - life taking) Guda Marma possesses a threat to life immediately after getting injured.

6.    LITERATURE REVIEW OF DISEASE

6.1 Definition

“अरिवद्विशसन्तीत्यर्शांसि| तानि पुनर्बहुप्रकाराणि|

सुबहूपद्रवाणि च| पायुमेढ्रादिसंश्रया मांसकीलाः||२||” (A. H. Ni. 7/2)

The disease which troubles a person’s vital force (prana) like enemy is termed as Arsha. It has many types and causes many complications. It is an abnormal fleshy growth (masa keela) which can occur in various site and organ like Guda, Medhra, etc.

6.2 Etiology (Nidana) of Arsha

The causes have been thoroughly explained by Nidana of Arsha Charaka.¹⁹ Sahaja Arshas is the result of the parents unwholesome behaviour and past deeds.²⁰ Incorrect Ahara and Vihara have a part in the development of Arshas, according to Sushruta. Both Charaka and Sushruta’s perspectives were merged by Vagbhata.²¹

Followings are some general categories for the aetiology:

• Based on dietary characteristics, including excessive or inadequate intake of incompatible diets like Guru, Madhura, Sheeta, Abhishyandi, etc.

• Based on Habits: Excessive straining, excessive sexual indulgence, or the repression of natural desires.

• Based on local irritant factors such as improper seating, unlevelled or harsh chairs, and prolonged vehicle rides.

According to Mandagni- Arshas, Grahani and Atisara are mutually causal.

• Based on therapeutic abuses, such as excessive oleation therapy, ineffective evacuation therapy, inappropriate Vastikarma administration, etc.

The detailed causal factors have been portrayed in Nidana of Arsha Charaka.

• Sahaja Arshas is accountable for the guardians’ bad behaviour and past actions. Sushruta also establishes the role of the foolish Ahara and Vihara in the origin of Arshas.

The opinions on both Charaka and Sushruta were solidified by Vagbhata.

• poorly planned arrangements for vastikarma, etc.

• using a hereditary component Sahaja arsha’s aetiology has also been interpreted as having a hereditary component.

• several causes—pregnancy.

6.3 Samprapti (Pathogenesis):

Virruddhahara, Adhyasana, irregular diet habits, over riding etc.

↓

suppression of Apana Vayu, Mandagni and constipation.

↓

Vitiation of Doshas and involvement of Rakta which travels

through pradhana dhamani and affects Gudavali.

↓

Involves Meda, Mamsa, and Twak representing anal cushions.

↓

Fleshy mass i.e. Hemorrhoids.

6.4 Arsha’s classification

1. Considering the source Arsha basically comes in two varieties.²²

• Sahaja Arsha - Congenital Hereditary

• Kalaja- which means one gained after birth.

2. Considering the characteristics of bleeding²³

• Ardra (Sravi): Pitta and Rakta Dosha vitiation causing bleeding piles.

• Shushka: As a result of Vata and Kapha Dosha vitiation, non-bleeding piles occurs.

3. In accordance with site²⁴

• Bahya (Samvarani),

• Abhyantara (Visarjini, Pravahani),

4. Based on the prognosis²⁵

• Sadhya (Healing)

• Yapya, second (Palliative)

• Asadhya (Incurable), third

5. Based on Arsha’s Chikitsa

Four therapeutic modalities for Arsha have been documented by Acharya Sushruta,²⁶ and these are used depending on the degree of Dosha involvement and the stage of Arsha.

1. Bheshaja Karma (Medical Treatment)

2. Shastra Karma (Surgery Management)

3. Kshara Karma (chemical cauterization)

4. Agni Karma (Cauterization)

6.5 Symptoms of Arsha

Loss of appetite, anal pain, constipation problems, bodily oedema, anxiety, headache, vomiting, lethargy, rectal bleeding, back pain, and emaciation are among the main clinical symptoms of Arsha.²⁷

7.    PREVIOUS WORK DONE

1.     REVIEW OF ARSHA AS PER SUSHRUTA SAMHITA - CLASSIFICATION AND PRINCIPLES OF MANAGEMENT

Dr. Shivanand A. Kembhavi, Dr. Muralidhara Sharma, Dr. Hemanth Toshikhane. Review of Arsha as per Sushruta Samhita - Classification and principles of management. J Ayurveda Integr Med Sci 2020;3:68-74.

Arsho roga explained in Ayurveda is not only haemorrhoidal pathology and includes all ano-rectal pathologies. Etiological factor of this disease is mainly the impaired dietetics and poor digestive fire. Hence mere concentrating our treatment plans on local changes in anal canal will not suffice. Correcting impaired digestive fire should be the prime motto of the treatment. Pittaja and Kaphaja variety of the Arshas can be co-related to the different hemorrhoidal conditions. Following the specific indication mentioned by Sushrut is important to get better results. These indications are relevant till now in deciding indications for medical, Para surgical or surgical treatment for the hemorrhoids. Ayurveda has major role to play in the treatment of this disease as we treat this disease as systemic illness and not the local illness.

2.     A LITRARY REVIEW ON: ARSHA WSR TO HAEMMORRHOIDS- by Dr. Rajesh Kumar Soni, Dr. Rajesh Gupta, Dr. Sudesh Rani Gupta, Dr. Mahendra Lodha- Dept. of Shalya tantra- WJPMR 2020

3. STUDY ON CONCEPT OF GUDA PRADESHA W.S.R. TO GUDA VALIS

M. R. Patil, Pennagaddam Dhananjayulu, Kavitha Butali. Study on concept of Guda Pradesha w.s.r. to Guda Valis. J Ayurveda Integr Med Sci 2022;8:67-71.

On the basis of review literature, the following deductions can be drawn, 1. Guda means the organ, which excretes the Apana Vayu and Mala. 2. Guda is a Sadyopranahara Marma 3. Guda has two parts - Uttara Guda (proximal part) and Adhara Guda (distal or Terminal part). 4. Guda (anus) are ‘Matruja’ in origin. 5. So finally, Valis are both functional as well as structural entities of Guda.

Modern medicine emphasize two sphincters but Ayurveda says Guda possess three Valis (fold like structures) which are said to be similar to the sphincter functions. Difference in the number, variation in measurements and Anatomical complexities of Guda Pradesha compels to have a deep study of the both Ayurvedic and modern Aspects and their comparison to clear the doubts of Ayurvedic descriptions and present day understanding of the subject. Anatomical relations with other structures and organs explained in Ayurveda with modern descriptions need to be studied.

4.     Study of Ayurvediya Guda Sharir and GudaValis in Comparison with  Modern Anatomy 

Yende M, Tawalare K, Gohane J, Thosar S. Study of Ayurvediya  Guda  Sharir  and  Guda  Valis  in Comparison  with  Modern  Anatomy.  AYUSH: International Research Journal of Ayurveda Teachers Association. 2023;2(1)37-40.

It can be inferred based on functionality and anatomical similarities found  during  the  study  that  the  following deductions are feasible to correlate guda with the rectum part of the large intestine. Three guda valis can correlate with the three transverse folds of the rectum. Pravahini can be considered as the largest Housten valve. Visarjani can be considered as the internal anal sphincter. Samvarani can be considered as the external anal sphincter. Uttarguda is the seat for faecal collection and adharguda for evacuation of the stools.

5.     A COMPREHENSIVE STUDY OF GUDA WITH SPECIAL REFERENCE TO GUDAVALI

Dr. Sharma mayank, Prof. ( Dr. ) Tripathi Renu,Dr. Dwivedi Ashok Kumar, Dr. K.V Mini, A Comprehensive study of guda with special reference to Guda-vali,World journal  of pharmaceutical and life sciences,2021, vol. 7,Issue7,177-181

The extent of Guda ranges from Gudoushtha till the termination of the Sthoola Antra. Guda can definitely be accepted as a Karmendriya, which serves the function of expulsion of Mala and Apana Vayu from the body. It can be accepted as a Koshthanga, comprising of two different entities viz. Uttar Guda and Adhara Guda. Among these, the proximally present Uttar Guda acts as temporary reservoir of the Mala while the distally present Adhara Guda assists in defecation. Hence, Uttar Guda can be co-related to the part of rectum from rectal ampulla (2nd transverse fold) till the inferior transverse fold while Adhara Guda can be co- related to the part below the inferior transverse fold till anal verge. The three Vali – Pravahani, Visarjani and Samvarani, assist in the function of defecation by forcing the Mala downwards, relaxing the Guda and contracting the Guda, respectively. This concept of our great Acharya is appreciable and can be understood and co-related with the contemporary science. Hence, these three Vali can be co-related to the Middle transverse fold, Inferior transverse fold of the Rectum and the region of the Anorectal ring (comprising of the puborectalis muscle, the external anal sphincter and the internal anal sphincter), respectively.

8.    AIM 

To anatomically assess Guda vali in relation to prevalence of Shushka and Ardra arsha.

9.     OBJECTIVES

9.1 Primary

•       To do the anatomical assessment of guda vali.

•       To find out the prevalence of shushka and ardra arsha.

9.2 Secondary

•       To find out the probable difference in the prevalence of shushka and ardra arsha.

10.  Materials and methods

10.1 Source of Data:

Literary Source: All the Ayurvedic, modern literatures and contemporary texts including the journals, websites were reviewed and documented about the disease.

Clinical Source: Patients of Arsha (Hemorrhoids) will be selected from Shalya Tantra OPD/IPD of Chaudhary Brahma Prakash Ayurved Charaka Sansthan, Najafgarh , Delhi-73.

10.2 Method of the study:

·       STEP 1: Study participants having clinical symptoms related to the study will be selected from the OPD of Dept. of Shalya tantra in Chaudhary Brahm Prakash Ayurved Charak Sansthan Hospital, Khera Dabar.

·       STEP 2: Enrolled subjects will be informed about the study through information sheet & written consent, as explained to them & their subject participation will be solicited.

·       STEP 3: After getting written consent from subjects, detailed history of the patient will be taken.

·       STEP 4: Then the anal canal of the subjects will be assessed by first visual inspection, then Digital rectal examination and lastly internal examination by Proctoscope. 

·       STEP 5: The type of Arsha will be identified and its site in anal canal will be assessed.     

·       STEP 6: After having data of all patients, the prevalence of both Shushka and Ardra Arsha in each Guda vali will be calculated.

·       STEP 7: Collected data will be statistically analyzed, compiled and presented in the form of thesis later.

10.3 Study population: 80 patients of Arsha between 25 – 50 years of age irrespective of gender, caste and religion will be assessed.

10.4 Study plan:  Prevalence of Shushka and Ardra Arsha in different Guda Vali will be assessed by inspection, digital rectal examination, Proctoscopy and Angula Pramana of Patient.

10.5 Study period: 12 months

10.6 Study Design: Cross sectional survey

10.7 Stastical test: Point prevalence

Point prevalence measures the proportion of a population that has a characteristic at a given point in time.

The prevalence formula used to determine the point prevalence of an illness is:

Point prevalence = (no. of cases of illness) / (total no. of all cases at that time)

Hence, the number of cases of Shushka and Ardra Arsha in each Guda vali will be calculated and will be divided by the total number of Arsha cases.

The resulting decimal will be multiplied by 100 to convert to a percentage.

10.8 Exposure variable: Guda Vali

10.9 Outcome variable: Shushka and Ardra Arsha prevalence

10.10 Study location: Shalya Tantra OPD/IPD of Chaudhary Brahma Prakash Ayurved Charaka Sansthan, Najafgarh, Delhi-73.

10.11 Assessment Criteria

•       Inspection: Without touching the part, condition of anus and surrounding peri anal skin will be examined for any pathology like inflammation, injury and any disease which was not desirable treatment point of view.

•       Palpation: (Digital Examination) The per rectal digital examination conducted to elicit tenderness, swelling, induration, to sphincter i.e. normal, spasmodic or relaxed etc.

•       Proctoscopic Examination:

Following findings of pile masses will be noted as mentioned below:

1)    Site - Internal/ External/ Interno-external

2)    Size -- < 1/2 Inch, 1/2 Inch, 1 Inch

3)    Surface - Uneven / Even / Smooth

4)    Position - Primary- 3 / 7 / 11 O’clock or Secondary.

11. ELIGIBLITY CRTERIA

11.1 Inclusion Criteria

·       Patients between 25-50 years of age, irrespective of gender, caste, and religion will be included.

·       Patients who had been pre-diagnosed with Arsha and newly diagnosed patients of Arsha.

·       Patients of Arsha irrespective of its degree.

·       Subjects who are ready to give consent for digital rectal examination and proctoscopy with firm residential address and contact numbers.

11.2 Exclusion Criteria:

• Patients of Arsha with associated fissure-in-ano, fistula-in-ano and rectal prolapse.
• Patients of Arsha with secondary complications.
• Patient who are suffering with diabetes mellitus, Tuberculosis, HIV, Hepatitis B and other congenital diseases, malignancy cases.
• Pregnancy induced piles.
• Patients below 25yrs and above 50yrs.

12. EXPECTED OUTCOME

• The knowledge of prevalence of Arsha in different guda valis will help to understand the variable complexities of Shushka and Ardra Arsha roga according to Acharya Charak. Also the knowledge of Guda Valis will be refreshed.
• This study will pave a new pathway to understand prognosis of Arsha based on position of Guda Vali. Also, it will help to explore newer treatment modalities of Arsha.