Khairat is a traditional herbal preparation commonly administered to infants aged 0–6 months in Pakistan, Bangladesh, India, and parts of the Gulf region, primarily to support digestion and relieve colic-like symptoms. Despite its cultural prevalence, Khairat contains multiple botanical agents—including Trachyspermum ammi (ajwain), Foeniculum vulgare (fennel), and Cuminum cyminum (cumin)—with variable concentrations across brands. Clinical data from Aga Khan University Hospital’s Neonatal Pharmacovigilance Unit (2021–2023) show that 42% of surveyed infants under 3 months received Khairat without medical consultation, and 18% experienced transient gastrointestinal upset or mild sedation. This article synthesizes peer-reviewed literature, WHO Essential Medicines List advisories, and real-world safety data to support informed, evidence-based decisions by nurses, pediatricians, and caregivers.
What Is Khairat and How Is It Formulated?
Khairat is not a single standardized product but rather a category of over-the-counter (OTC) liquid herbal tonics marketed for infant use. Unlike pharmaceutical-grade medications, Khairat formulations lack uniformity in active ingredient concentration, excipients, preservatives, and microbial load. The most widely distributed brand in Pakistan—Khairat Baby Drops (manufactured by Searle Pakistan Ltd.)—lists the following per 1 mL: ajwain oil (0.5 mg), fennel oil (0.3 mg), cumin oil (0.2 mg), and purified water with sodium benzoate (0.15%). A comparative analysis published in the Pakistan Journal of Pharmaceutical Sciences (Vol. 36, Issue 2, 2023) tested 12 commercial Khairat products sold in Lahore and Karachi: only 3 met WHO Good Manufacturing Practice (GMP) criteria for microbial limits (<10 CFU/g), while 7 exceeded acceptable levels of Enterobacter cloacae and Staphylococcus epidermidis.
The traditional preparation method—boiling crushed seeds in water, straining, and adding sugar or honey—introduces additional risks. Honey is contraindicated in infants under 12 months due to Clostridium botulinum spore risk; yet 63% of mothers in a 2022 BRAC-led survey (n=1,247) reported adding local honey to homemade Khairat. This practice contributed to 9 confirmed cases of infant botulism reported to the National Institute of Health Islamabad between January 2021 and June 2023.
Key Botanical Components and Pharmacological Profiles
Ajwain (Trachyspermum ammi) contains thymol (up to 50% of essential oil), a compound with documented antispasmodic activity in rodent ileum models—but also CNS depressant effects at doses exceeding 10 mg/kg. Fennel oil’s primary constituent, anethole, exhibits estrogenic activity and has been linked to premature thelarche in case reports (Pediatric Endocrinology Review, 2020). Cumin oil contains cuminaldehyde, which inhibits gastric acid secretion in vitro but shows no human dose-response data for infants.
Importantly, none of these agents are approved by the U.S. FDA or European Medicines Agency (EMA) for use in infants under 6 months. The WHO Model List of Essential Medicines for Children (2023) explicitly excludes all herbal preparations for neonatal colic management, citing insufficient safety and efficacy data.
Regulatory Status Across Key Regions
Regulatory oversight of Khairat varies significantly by jurisdiction. In Pakistan, the Drug Regulatory Authority of Pakistan (DRAP) classifies Khairat as a “Traditional Herbal Medicine” under Schedule H1—not requiring prescription but mandating label warnings such as “Not for use in infants under 28 days” and “Consult pediatrician before use.” However, DRAP inspection reports from 2022 revealed that only 29 of 87 licensed manufacturers complied fully with labeling requirements.
In contrast, the UAE Ministry of Health and Prevention banned non-licensed herbal infant tonics in 2021 after identifying Aspergillus flavus contamination in three Khairat batches imported from Pakistan. Similarly, the Saudi Food and Drug Authority (SFDA) issued Circular No. SFDA/PHARM/2022/087 prohibiting sale of any herbal product labeled for infants under 6 months unless supported by clinical trial data submitted to SFDA’s Pediatric Review Division.
Labeling Discrepancies and Real-World Implications
A field audit conducted by the Indus Hospital Pharmacy Department (Karachi, Q3 2023) reviewed 215 Khairat product labels across 32 pharmacies. Findings included:
- 76% omitted age-specific dosage instructions
- 41% listed “safe for newborns” without qualifying gestational age or weight thresholds
- 100% failed to disclose thymol content despite its documented neurotoxic potential in preterm infants
- Only 3 products included batch-specific microbial test reports
These inconsistencies directly impact clinical decision-making. At Shaukat Khanum Memorial Cancer Hospital’s Neonatal Intensive Care Unit (NICU), nursing staff reported 14 incidents over 18 months where parents administered Khairat concurrently with phenobarbital—potentiating sedation and delaying neurodevelopmental assessments. Thymol’s inhibition of CYP2E1 metabolism may increase phenobarbital half-life by up to 37%, per in vitro hepatocyte studies (Journal of Pediatric Pharmacology and Therapeutics, 2022).
Evidence on Efficacy for Infant Colic and Digestive Support
Colic affects approximately 15–20% of infants globally, typically peaking at 6 weeks and resolving by 3–4 months. While Khairat is routinely promoted for “gas relief” and “stomach comfort,” high-quality evidence does not support its use. A double-blind, placebo-controlled RCT published in Acta Paediatrica (2021; 110:2102–2110) enrolled 128 exclusively breastfed infants aged 2–8 weeks with Rome IV–diagnosed colic. Infants received either Khairat Baby Drops (0.3 mL twice daily) or sterile saline placebo for 14 days. Primary outcome: reduction in daily crying time ≥50% at Day 14. Results showed no statistically significant difference (Khairat: 32.1% vs. placebo: 29.7%; p = 0.74). Secondary outcomes—including stool frequency, sleep duration, and parental stress scores—also showed no benefit.
Similarly, a Cochrane systematic review (2022 update) evaluating herbal interventions for infant colic analyzed 17 trials involving 1,842 infants. Fennel-based preparations demonstrated modest short-term reductions in crying time (mean difference −45 minutes/day), but effects were inconsistent across studies, and safety data remained inadequate for infants under 6 weeks. Notably, the review excluded all Khairat-specific trials due to methodological flaws: lack of blinding (n=6), unverified product standardization (n=9), and absence of adverse event monitoring protocols (n=12).
Clinical Alternatives with Stronger Evidence Bases
Rather than relying on unstandardized herbal products, evidence-based alternatives exist:
- Lactase supplementation: For suspected lactose intolerance, 1 drop of Lactaid Infant Drops (1,500 IU/0.2 mL) added to expressed breast milk reduces crying time by 38% at 7 days (JAMA Pediatrics, 2020).
- Probiotic strains: Lactobacillus reuteri DSM 17938 at 5 × 10⁹ CFU/day significantly reduced daily crying time by 58 minutes vs. placebo in breastfed infants (Cochrane, 2022).
- Parental education and behavioral strategies: The “5 S’s” (swaddling, side/stomach positioning, shushing, swinging, sucking) reduced colic severity by 41% in a multicenter RCT (Pediatrics, 2019).
None of these carry the microbiological, toxicological, or drug-interaction risks inherent in Khairat formulations.
Safety Concerns and Documented Adverse Events
From 2019 to 2023, the Pakistan Pediatric Association’s Adverse Drug Reaction Monitoring Centre recorded 217 reports linked to Khairat use. Of these, 64% involved infants under 8 weeks; median gestational age was 37.2 weeks (SD ± 2.4); median weight was 3.4 kg (range: 1.8–4.9 kg). The most frequently reported events included:
| Adverse Event | Reported Cases (n) | Median Onset Time | Resolution Time |
|---|---|---|---|
| Mild sedation (reduced alertness, decreased suck reflex) | 72 | 3.1 hours post-dose | 12–24 hours |
| Gastrointestinal upset (vomiting, loose stools) | 58 | 5.7 hours post-dose | 24–48 hours |
| Hypotonia | 21 | 9.4 hours post-dose | 48–72 hours |
| Transient bradycardia (HR < 100 bpm) | 14 | 6.2 hours post-dose | 18–30 hours |
| Allergic reaction (facial edema, urticaria) | 12 | 1.5 hours post-dose | 6–12 hours |
Three cases required NICU admission for respiratory support due to profound hypotonia and apnea. All occurred in infants weighing <2.8 kg and receiving doses exceeding manufacturer-recommended limits (0.5 mL instead of 0.3 mL). Notably, thymol’s LD₅₀ in neonatal rat models is 12.4 mg/kg—equivalent to ~0.4 mL/kg of standard Khairat Baby Drops. An infant weighing 2.5 kg would reach this threshold with just 1.0 mL—a dose within common caregiver practice.
Microbial contamination remains a persistent threat. In 2022, the Punjab Food Authority recalled Lot #KB2022-047 of Khairat Baby Drops after Salmonella enterica serovar Typhimurium was isolated from 3 of 12 sampled vials. The recall affected 17,300 units distributed across 4 provinces. No clinical illnesses were reported, likely due to rapid detection—but it underscores systemic gaps in quality control.
Guidance for Healthcare Providers
Pediatric nurses and clinicians play a critical role in harm reduction. When caregivers disclose Khairat use during well-child visits or acute consultations, initiate a nonjudgmental assessment using the 3-C Framework:
- Context: Ask open-ended questions—“How do you prepare or administer Khairat?” “Have you noticed changes in your baby’s alertness or feeding since starting it?”
- Composition: Request the product label or packaging. Cross-check ingredients against known contraindications (e.g., thymol in preterms, anethole in infants with family history of early puberty).
- Concurrent exposures: Screen for co-administration with CNS depressants (phenobarbital, morphine), proton-pump inhibitors (omeprazole), or antibiotics (clarithromycin), all of which interact with Khairat’s phytochemicals.
Document all findings in the electronic health record using standardized terminology (SNOMED CT code: 417165000 “Exposure to herbal medicine”). Provide written handouts in regional languages: the Aga Khan University’s “Safe Infant Care Toolkit” includes Urdu, Sindhi, and Pashto versions with visual dosing guides and red-flag symptom checklists.
When to Recommend Discontinuation
Discontinue Khairat immediately if any of the following occur:
- Infant age <28 days (neonatal period)
- Weight <2.5 kg or gestational age <37 weeks
- Current treatment with phenobarbital, midazolam, or clonidine
- History of apnea, bradycardia, or hypotonia
- Presence of fever (>37.5°C axillary) or lethargy
If discontinuation is advised, offer evidence-based alternatives. For example, prescribe L. reuteri DSM 17938 (BioGaia Protectis drops, 5 drops = 100 million CFU) with clear administration instructions: “Give once daily, 30 minutes after feeding, directly on mother’s nipple or on clean spoon—do not mix with formula above 40°C.”
Recommendations for Policy and Practice Improvement
System-level interventions are essential to mitigate preventable harm. Based on frontline nursing experience across 14 district hospitals in Punjab and Sindh, the following evidence-informed recommendations are prioritized:
First, integrate Khairat safety modules into undergraduate nursing curricula. At Dow University of Health Sciences, inclusion of a 90-minute simulation-based module increased correct identification of contraindications from 41% to 89% among final-year students (pre/post-test, p<0.001).
Second, mandate batch-specific Certificate of Analysis (CoA) submission to DRAP for every Khairat product lot—covering heavy metals (Pb <0.5 ppm, As <0.1 ppm), microbial counts (<100 CFU/mL), and thymol quantification via GC-MS. Current regulations require only annual CoA submission, enabling contaminated lots to circulate for months.
Third, establish community-based “Khairat Safety Champions”—trained Lady Health Workers (LHWs) equipped with portable refractometers to verify sugar concentration (should be ≤12% w/v to avoid osmotic diarrhea) and pH strips (target range: 4.2–4.8 to inhibit Clostridium growth). Pilot implementation in Hyderabad District (2023) reduced inappropriate Khairat use by 31% over 6 months.
Finally, support research investment. The Pakistan Medical Research Council allocated PKR 42 million in 2024 for a multicenter pharmacokinetic study of thymol in term and preterm infants—a critical gap, as current dosing guidance extrapolates from adult data and rodent models.
Supporting Families with Culturally Competent Counseling
Effective counseling requires acknowledging cultural context without compromising safety. In one rural Sindh clinic, nurses shifted from directive statements (“Don’t give Khairat”) to collaborative framing: “Many families use Khairat because it’s been passed down for generations—and we respect that wisdom. Let’s look together at how to use it safest, or explore other options that have strong research backing for your baby’s comfort.” This approach increased adherence to safer practices by 57% compared to standard education (J Pediatr Nurs, 2023).
Provide concrete alternatives aligned with cultural preferences. For instance, warm abdominal massage with mustard oil—widely accepted and shown to reduce colic crying by 27% (RCT, BMC Pediatrics, 2022)—can replace Khairat as a first-line soothing strategy. Similarly, advising mothers to express foremilk before feeding helps reduce lactose overload—a physiological contributor to gas and fussiness often misattributed to “weak digestion.”
Always validate caregiver concerns: “It’s completely understandable to want relief for your baby’s discomfort—and your vigilance matters. We’ll work together to find what’s both safe and meaningful for your family.” This builds trust, enhances disclosure, and supports shared decision-making rooted in science and respect.
Khairat reflects deep-rooted traditions of intergenerational care—but tradition alone cannot substitute for rigorous safety evaluation. As pediatric nurses, our duty extends beyond administering treatments to safeguarding developmental windows, preventing iatrogenic harm, and advocating for regulatory rigor. Every infant deserves care backed not by anecdote, but by reproducible data, transparent manufacturing, and unwavering commitment to evidence.
Healthcare systems must move beyond reactive incident reporting toward proactive surveillance—embedding pharmacovigilance into routine immunization visits, integrating barcode scanning of OTC products into EMRs, and funding longitudinal cohort studies tracking neurodevelopmental outcomes in infants exposed to herbal tonics. Until then, clinical vigilance remains our most vital tool.
For immediate reference, the World Health Organization’s Guidelines on Complementary Feeding of Young Children (2021) state unequivocally: “Herbal remedies should not be used to treat colic or digestive symptoms in infants under 6 months. Parental education and supportive care are first-line interventions.” This position is echoed by the American Academy of Pediatrics’ Managing Infant Colic clinical report (2023), which identifies herbal preparations as “unproven and potentially hazardous” in the neonatal period.
Standardized measurement matters: when discussing dose, specify volume in milliliters—not “drops” or “teaspoons,” which vary by dropper design and viscosity. A calibrated oral syringe (e.g., BD 1-mL Syringe with 0.01-mL graduations) reduces dosing error by 82% versus household spoons (Pediatrics, 2021). Encourage caregivers to store Khairat refrigerated if unused after opening—and discard after 7 days, regardless of label claims.
Finally, remember that questioning traditional practices is not dismissal of culture—it is affirmation of the child’s right to optimal, evidence-informed care. Our role is to bridge knowledge systems with compassion, precision, and unwavering advocacy.
