An Interventional Study to evaluate the effectiveness of Siddha formulation Gowri Chinthamani Chendooram along with Siddha line of treatment Seeraga thylam oilbath and Moolakudara thylam laxative in the treatment of Moolam (Haemorrhoids) among Out-patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennnai-47
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- National Institute Of Siddha
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement of Haemorrhoid Symptom Scoring (HSS) after treatment.
Study Overview
Brief Summary
BACKGROUND:
Siddha system of medicine is one of the traditional systems of medicine in India. The uniqueness of siddha system is evident by its continuous service to the mankind in combating diseases and also in maintaining its physical, mental and moral health. The diagnosis of disease in siddha system of medicine relies on eight diagnostic tools called Ennvagai Thervu such as Naadi, Sparisam, Naa, Niram, Mozhi, Vizhi, Malam, Moothiram which are evaluated in terms of three humors. Saint Agasthiyar identified 4448 diseases and one among them is Eruvai Mulai noi. Any derangements in humors results in development of diseases. Yugi mentioned the disease Moolam and its types in Yugi Vaithiya Chinthamani. This disease is mainly due to aggravated vatham and pitha humors. In Moola noi, deranged Vatha humor triggers keelvai kanal (abana vaayu) which in turn stimulates pitham humor resulting in Moolam with the symptoms of constipation, bleeding during defecation, pain in umbilical region, pallor of the body, headache, giddiness are developed. As per Siddha, Siddhars notify Moolatharam is a seat of Kundalini Sakthi (Energy point). Any irregular practice of yoga, food and lifestyle modifications may disturb the moolatharam and results in disease called Moolam. Haemorrhoids are a very common anorectal condition and is formed by a dilatation of veins in the external and internal haemorrhoidal plexuses. Clinically there are two types of Haemorrhoids viz. Internal Haemorrhoids and External Haemorrhoids. Based upon the protrusion of mass, it’s subdivided into 4 grades. Etiological factors include Constipation, a low fiber diet, a sedentary lifestyle, a high Body Mass Index, pregnancy, hereditary and are often assumed to increase the risk of haemorrhoidal disease (HD). The common presenting symptoms of haemorrhoids are the painless rectal bleeding, pruritus, fecal soilage, perianal irritation, or mucus discharge .Usual treatments provided for Haemorrhoids are conservative management includes stool softeners, bulking agents for stage 1and 2. Conditions Refractory to conservative management or stage 3 and 4 Hemorrhoids will be treated surgically . The recurrence rate after stapled hemorrhoidopexy and conventional hemorrhoidectomy 0 to 26 % and 0 to 10.8%, respectively; reoperation rate was 16.7 % after stapled hemorrhoidopexy. In Siddha system, the line of treatment for Moola noi has been designed as internal medicines, external therapies such as Kattu, Pattru, Poochu, Pugai, Kalimbu, Neer and Yoga maruthuvam. By following the siddha line of treatment for moolam along with proper dietary advise, the recurrence rate of the disease and the need for expensive surgeries can be mitigated.
OBJECTIVE:
To evaluate the effectiveness of siddha formulation GOWRI CHINTHAMANI CHENDOORAM in the treatment of MOOLAM( FIRST AND SECOND DEGREE HAEMORRHOIDS) among Haemorrhoids patients through proctoscopy and Haemorrhoid symptom scoring (HSS) before and after treatment.
STUDY DESIGN: This is an interventional study of Non randomized sampling which will be carried out for 6 months in patients with haemorrhoids reporting at OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai – 600 047 with 20 patients as sample size. Patients with Age ≥ 18 years and ≤ 60 years of Both sex, and Participants with First and second degree Haemorrhoids,
Participants with Haemorrhoid Symptom Scoring (HSS) ≥ 5, Participants willing to undergo proctoscopic examination, Participants willing to give blood samples for the investigations required will be included in this study. Patients with fissure in ano, fistula in ano, external haemorrhoids and pregnant and lactating women will be excluded from the study.
OUTCOME OF STUDY
Improvement of Haemorrhoid Symptom Scoring (HSS) after treatment.
Reduction in the size of the Pile mass in Proctoscopic examination after treatment
RESULTS AND DISCUSSION: The results will be statistically analysed and reported.
KEYWORDS: moolam, anorectal diseases, Gowri chinthamani chendooram.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Degree I – II Haemorrhoids
- •Participants with Haemorrhoid Symptom Scoring (HSS) ≥ 5
- •Participants willing to undergo proctoscopic examination
- •Participants willing to give blood samples for the investigations required.
Exclusion Criteria
- •1.Pregnancy and lactation.
- •2.Fistula in Ano 3.Fissure in Ano 4.External haemorrhoids.
Outcomes
Primary Outcomes
Improvement of Haemorrhoid Symptom Scoring (HSS) after treatment.
Time Frame: 6 months
Reduction in the size of the Pile mass in Proctoscopic examination after treatment.
Time Frame: 6 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Abirami S
National Institute of Siddha
