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Clinical Trials/CTRI/2024/06/069199
CTRI/2024/06/069199Not yet recruitingPhase 2

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

National Institute Of Siddha1 site in 1 country20 target enrollmentStarted: June 25, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
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

Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Abirami S

National Institute of Siddha

Study Sites (1)

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