跳至主要内容
临床试验/CTRI/2025/03/081856
CTRI/2025/03/081856招募中Phase 3 4

Evaluation of add on effect of Gugguladi Dhoopana Varti with topical Khanduchakka ointment against topical Khanduchakka ointment alone in the management of post-operative Anorectal wounds.

Datta Meghe Institute Of Higher Education And Research1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
Phase 3 4
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Wound healing and analgesia in post-operative Anorectal wounds

研究概览

简要总结

The most traditional medical system is Ayurveda. The objectives of this science of life are to maintain and improve health as well as to eradicate illness. The three fundamental Ayurvedic aphorisms- Hetu (causes), Linga (symptoms), and Aushadha (therapeutics) —form the foundation of the entire science of Ayurveda. Of these three, Aushadha is crucial to medicine (Chikitsa) because it is the initial stage of disease treatment. Fistula-in-Ano can be correlated with Bhagandara, is a chronically abnormal connection that runs from the ano-rectum to the peri-anal skin and is surrounded by unhealthy granulation tissue. It develops as an external opening on the buttock or perineum as boil also known as Bhagandara Pidika in *Ayurveda.*Fistula in ano is a crypto-glandular genesis, with inappropriate anal gland drainage and crypto-glandular infection being the primary causes of fistulous tract formation. It can result in discomfort, edema, discharge, and itching. Classification of Fistula in Ano according to Sir Alan Park’s are intersphincteric, trans sphincteric, suprasphincteric, and extra sphincteric. The prevalence of a fistula-in-ano developing from a perianal abscess range between 26% and 38%. Fistulotomy and fistulectomy, are the conventional surgical techniques and newer sphincter saving methods are developed such as use of fibrin glue, fistula plugs, Video-Assisted Anal Fistula Treatment (VAAFT), Ligation of The Intersphincteric Fistula Tract (LIFT), Interception of Fistulous Tract and Application of Ksharsutra (IFTAK).

One of the eight major diseases of Ashtamahagadas is fistula. Sushruta states that a Bhangandara is a tear (Darana) of the perianal region (Bhaga), anus (Guda), and bladder (Basti) with surrounding skin surface. According to the predominance of Doshas, Sushruta has divided the disease into five categories: Vataja- Shataponak, Pittaja-Ushtragreeva, Kaphaja-Parisrave, Tridoshaja-Shambookavarta, and Abhighataj/Trauma-Unmargee. Vagbhata has listed three other types of Bhagandara: Pitta and Kapha dominance: Arshobhagandara (Piles fistula), Vata and Pitta dominance:Parikshepee (horseshoe-shaped fistula), and Vata and Kapha dominance: Riju (straight). Ksharasutra therapyis a widely recognized technique that has the lower recurrence rate (3.33%) amongst all techniques utilized for fistulas in ano. Sterilization is a critical process in various fields, including medicine, pharmaceuticals, food production, and scientific research, aimed at eliminating all forms of microbial life, including bacteria, viruses, fungi, and spores. The primary objective of sterilization is to ensure the safety and efficacy of products and procedures by preventing contamination and infection. Dhoopana karma is a natural and traditional method that can be useful in controlling infections. Dhoopana Karma, mentioned in Samhita, presents a promising avenue for clinical application, but nowadays it is underutilized in clinical practices. It stands as an economically prudent option for patient care, serving as a viable alternative to costly and intrusive interventions and possessing strong wound healing and antimicrobial properties. Dhoopana drugs reduce inflammation and promote tissue regeneration for faster healing, preventing infections in anorectal wounds as they are most prone to infection and delayed wound healing. Dhoopana karma with certain medicated herbs will give anti-inflammatory, antimicrobial, and wound healing effects, minimizing the need for antibiotics and steroids. Dhoopana karma helps to prevent the introduction of microorganisms that can cause infections. Dhoopana karma promotes healing, viz., proper sterilization and care; promotes faster and more effective healing of surgical sites; reduces complications; minimizes the risk of infection; reduces the likelihood of complications, such as sepsis or delayed wound healing. Sitz bath is a lukewarm, shallow bath that cleanses and gives local swedan (fomentation) to the perianal region. It gives relief from pain, inflammation, swelling, and irritation in the perianal region. Sushruta Acharya stated; Gugguladi Dhoopana Varti provides relief from the pain of Arsha and Shotha, while Povidone-iodine is a broad-spectrum antiseptic and used in the management of wound healing and prevention of infections. So, an attempt will be made to evaluate the effect of Gugguladi Dhoopana karma with sitz bath with hot water in the treatment of postoperative fistula wounds. Aim of this study is to evaluate the efficacy of Dhoopana Karma in post-operative Anorectal wounds

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients willing with written informed consent.
  • Patients with age group 18-60 years.
  • Patients with post operative proctology wound will be included after screening.
  • Patients irrespective of sex, occupation and economic status will be included.

排除标准

  • Immuno-suppressed patients and taking immuno-suppressive medication.
  • Patients having Asthma 3) Uncontrolled diabetes 4) HbsAg reactive patients 5) HIV positive patients 6) Tuberculosis positive patients 7) Known cases of Malignancy.

结局指标

主要结局

Wound healing and analgesia in post-operative Anorectal wounds

时间窗: 30 Days

次要结局

  • No Recurrence(15 Days)

研究者

发起方
Datta Meghe Institute Of Higher Education And Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Sakshi Ghugal

Mahatma Gandhi Ayurved College And Research Centre, Salod Hirapur

研究点 (1)

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