A Clinical Study to Evaluate the Efficacy of Himsradi Taila Pichu in the Management of Parikartika W.S.R to Acute Fissure-in-Ano

Parikartika is a painful anorectal disorder described in Ayurvedic classics, characterized by cutting pain (kartanavat vedana), burning sensation (daha), bleeding per rectum, and difficulty during defecation¹. Acharya Susruta describes Parikartika in the context of guda sthana gata roga and as an upadrava of improper sodhana procedures, emphasizing the role of aggravated Vata and Pitta².

 

Clinically, the symptomatology of Parikartika closely resembles acute fissure-in-ano as described in modern medicine³.

 

Acute fissure-in-ano is a common condition encountered in Shalya Tantra outpatient practice and is associated with severe pain, sphincter spasm, constipation, and bleeding during defecation⁴. If not managed appropriately in the early stage, it may progress to a chronic condition requiring surgical intervention. Hence, early conservative management plays a crucial role in preventing chronicity.

 

Ayurveda advocates Sthanika Chikitsa for disorders of the guda region, among which Pichu Karma is a simple and effective local therapeutic modality⁵. Pichu involves the application of sterile cotton or gauze soaked in medicated oil to the affected area, allowing prolonged contact of the drug with the lesion. In anorectal disorders, Taila Pichu pacifies aggravated Vata, relieves pain and sphincter spasm, reduces local irritation, and promotes wound healing.⁶

 

The major advantage of Pichu lies in its simplicity, safety, and suitability for OPD-based management. It does not require anesthesia or hospitalization and is well accepted by patients, making it an economical and practical treatment option for acute fissure-in-ano.

 

Before undertaking a large-scale clinical trial, a pilot study was planned to assess feasibility, safety, patient compliance, and preliminary efficacy of Himsradi Taila Pichu, a classical formulation described for vrana-roga and vata-pitta predominant conditions.

 

AIM:

To evaluate the feasibility, safety, and preliminary efficacy of Himsradi Taila Pichu in the management of Parikartika with special reference to acute fissure-in-ano.

 

OBJECTIVES:

1.To assess the effect of Himsradi Taila Pichu on pain

2.To observe its effect on bleeding per rectum

3.To evaluate changes in sphincter tone

4.To assess improvement in constipation

5.To observe fissure healing

6.To assess patient compliance and safety

·        Study Design: Pilot clinical study (single-group, open-label).

·        Sample Size: 15 patients.

·        Source of Data: Patients attending the OPD of Shalya Tantra.

 

Inclusion Criteria:

·        Patients aged 18–60 years

·        Clinically diagnosed cases of acute fissure-in-ano Presence of pain with or without bleeding

 

Exclusion Criteria:

·        Chronic fissure-in-ano

·        Associated anorectal conditions such as fistula or hemorrhoids Systemic diseases affecting wound healing

·        Pregnant and lactating women

 

INTERVENTION:

Drug: Himsradi Taila

 

Procedure: Taila Pichu

After proper local hygiene, sterile cotton gauze soaked in Himsradi Taila was applied locally in the anal canal once daily. Patients were advised dietary modifications to avoid constipation.

 

ASSESSMENT CRITERIA:

·        Pain

·        Bleeding

·        Sphincter tone

·        Constipation

 

HIMSRADI TAILA:

Himsradi Taila was prepared according to classical Ayurvedic principles of Sneha Kalpana. The formulation consisted of Himsra, Haridra, Kaṭuki, and Bilva mula as prime ingredients, with Tila Taila used as the base oil.⁷ The herbal drugs were cleaned, dried, and coarsely powdered. A decoction was prepared by boiling the coarse powders in water and reducing it to one-fourth of the initial volume. The decoction was then filtered and mixed with Tila Taila in the prescribed classical proportion. The mixture was heated on a mild flame with continuous stirring until Sneha Siddhi Laksanas were attained. The prepared oil was filtered and stored in airtight containers.

 

OBSERVATIONS:

In this pilot study:

·        The majority of patients were young and middle-aged adults.

·        In the present pilot study, all 15 patients (100%) presented with pain, bleeding per rectum, constipation, and increased sphincter tone at baseline. These symptoms were inter-related and formed a vicious cycle responsible for persistence of the fissure.

 

RESULTS

A total of 15 patients of Parikartikā (acute fissure-in-ano) were included in the study.

 

The mean pain score reduced from 2.60 at baseline to 1.80 on Day 7, 0.93 on Day 14, 0.40 on Day 21, and 0.00 by Day 28, showing 100% pain relief (p < 0.001). The mean bleeding score decreased from 1.60 at baseline to 0.67 on Day 7, 0.13 on Day 14, with complete cessation by Day 21, which persisted through Day 28 (p ≤ 0.002). Mean sphincter tone score reduced from 1.80 at baseline to 0.87 on Day 7, 0.27 on Day 14, and 0.00 by Day 21, indicating 100% normalization (p = 0.001).

 

Constipation scores declined from 2.13 at baseline to 1.13 on Day 7, 0.40 on Day 14, 0.07 on Day 21, with complete relief by Day 28 (p < 0.001).

 

Overall, treatment with Himsradi Taila Pichu produced rapid and consistent improvement in all clinical parameters. Complete relief in pain, bleeding, constipation, and sphincter spasm was achieved within 28 days in all patients. The progressive and statistically significant reduction in symptom scores from the first week onwards indicates a strong therapeutic response. The intervention was well tolerated, with no adverse effects, demonstrating its effectiveness and suitability as an OPD-based conservative treatment for acute fissure-in-ano.

The clinical improvement observed in the present study can be directly correlated with the pharmacological actions of the individual ingredients of Himsradi Taila, as documented in classical and drug-review data. The progressive reduction in mean pain score from 2.60 at baseline to 0.00 by Day 28 can be attributed to Himsra, Bilva, Bala, and Tila Taila, all of which possess vedanasthapana and vatasamaka properties. These drugs helped in reducing neural irritation and reflex sphincter spasm, leading to sustained pain relief.

 

The marked reduction in bleeding (mean score 1.60 to 0.00 by Day 21) is explained by the vrana-ropana, stambhana, and rakta-prasadana actions of Haridra,

 

Gojihva, and Bilva, which reduced local inflammation, promoted wound stabilization, and prevented recurrent oozing from the fissure site.

 

The complete normalization of sphincter tone (mean score 1.80 to 0.00 by Day 21) is mainly due to the snigdha, guru, and vata hara nature of Tila Taila and Bala, which soften tissues, relax the anal musculature, and improve local circulation. Reduction of sphincter spasm played a central role in breaking the pain–spasm cycle and facilitating healing.⁸

 

Improvement in constipation (mean score 2.13 to 0.00 by Day 28) is primarily due to the lubricating and mridukara action of Tila Taila, which reduced friction during defecation, along with indirect vata anulomana achieved through sphincter relaxation. Katuka further contributed by reducing local inflammation and supporting tissue repair, thereby preventing painful defecation and fear-induced stool withholding.⁹

 

Thus, the combined action of Himsradi Taila ingredients analgesic (Himsra, Bilva, Bala),

sphincter-relaxing and lubricating (Tila Taila, Bala), hemostatic and wound-healing (Haridra, Gojihva, Bilva), and anti-inflammatory (Katuka) explains the uniform and complete reduction in mean scores across all clinical parameters.

 

CONCLUSION

Himsradi Taila Pichu produced complete clinical improvement in Parikartika by effectively relieving pain, controlling bleeding, normalizing sphincter tone, and correcting constipation. Pain relief was primarily attributed to Himsra and Bilva, sphincter relaxation and bowel regulation to Tila Taila, and bleeding control with wound healing to Haridra, Gojihva, and Bilva, while Katuka supported reduction of local inflammation and tissue repair. The synergistic action of these ingredients successfully interrupted the pain–spasm–constipation cycle, establishing Himsradi Taila Pichu as a safe, effective, and practical OPD-based conservative treatment for acute fissure-in-ano.

 

LIMITATION OF THE STUDY:

The main limitation of this study was the small sample size and limited follow-up period. Future studies involving larger populations, longer follow-up, and objective imaging or microbiological assessments would help further validate these findings.

 

STATISTICAL GRAPHS AND CHARTS:

1.      Susruta. Suśruta Saṃhitā. Ambikā Datta Śāstrī, commentator. Āyurveda-Tattva-Sandīpikā commentary. Sūtra Sthāna & Chikitsā Sthāna. Reprint ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2018. p. 268–269.

2.      Susruta. Suśruta Saṃhitā. Ambikā Datta Śāstrī, commentator. Āyurveda-Tattva-Sandīpikā commentary. Chikitsā Sthāna (Basti–Virecana Vyāpada Adhyāya). Reprint ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2018. p. 305–306.

3.      Goligher JC. Surgery of the anus, rectum and colon. 5th ed. London: Baillière Tindall; 1984. p. 150–154.

4.      Goligher JC. Surgery of the anus, rectum and colon. 5th ed. London: Baillière Tindall; 1984. p. 150–154.

5.      Susruta. Suśruta Saṃhitā. Ambikā Datta Śāstrī, commentator. Āyurveda-Tattva-Sandīpikā commentary. Chikitsā Sthāna (Vrana Chikitsā &

6.      Guda-roga Prakaraṇa). Reprint ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2018. p. 20–22, 303–306.

7.      Sarangadhara. Śārṅgadhara Saṃhitā. Madhyama Khaṇḍa (Sneha Kalpanā Adhyāya). Reprint ed. Varanasi: Chaukhambha Surbharati Prakashan; 2018. p. 212–218.

8.      Suśruta. Suśruta Saṃhitā. Ambikā Datta Śāstrī, commentator. Āyurveda-Tattva-Sandīpikā commentary. Chikitsā Sthāna (Vrana Chikitsā Adhyāya 17/19). Reprint ed. Varanasi: Chaukhambha Sanskrit Sansthan; 2018. p. 287–289.

9.      Schouten WR, Briel JW, Auwerda JJ. Relationship between anal pressure, anodermal blood flow, and healing of anal fissures. Dis Colon Rectum. 1994;37(7):664–669.

10.   Bhāvamiśra. Bhāvaprakāśa Nighaṇṭu. Harītakyādi Varga (Katukā). Reprint ed. Varanasi: Chaukhambha Orientalia; 2018. p. 179–181.