Comparative efficacy of Haridrakhanda and Haridrakhanda without milk in Sheetapitta
- Conditions
- Diseases of the skin and subcutaneous tissue, (2) ICD-10 Condition: L50||Urticaria, (3) ICD-10 Condition: L50||Urticaria, (4) ICD-10 Condition: L50||Urticaria,
- Registration Number
- CTRI/2020/04/024439
- Lead Sponsor
- IPGT and RA
- Brief Summary
This is an double blinded randomization comparative clinical trial to study the efficacy of Haridrakhanda prepared with milk and without milk and their efficacy on sheetapitta.Haridrakhanda is an important Ayurvedic herbo-mineral preparation used in Urticaria as per Ayurvedic classics and previous research works. There are three groups for the study purpose. In group A Haridrakhanda prepared with milk dose 6 gm twice a day will be carried out. In group B Haridrakhanda prepared without milk dose 6 gm twice a day will be carried out. in Group C tab cetrizine 10mg/once at night will be carried out throughout the treatment schedule of 6 weeks. Follow up period is 4 weeks for all groups. In this study, total66 patients were registered by dividing into three groups, 22 in group A, 22 ingroup B and 22 in group C. Total 60 patients were completed the treatment with *Haridrakhanda*prepared with milk and without milk and Four patients were shifted to otherplace, whereas two patients were left the course of the treatment due toinevitable personal reasons. Total 60 patientsi.e. 20 patients in each group were completed the treatment.Majorityof the patients (46.96%) belongs to the age group of 30-40 years while 59.06%patients were females and 98.48% were Hindu.49.96% patients were suffering fromurticaria since 7-12 months. Maximum numbers of patients i.e. In 63.18%patients, episode of urticaria was seen more in winter. Episode of urticariawas more seen at morning time in 21.21% patients. Around43.93% patients were taking allopathic medication historywhile 96.96% of the patients didn’t have any family history.13.63%patients were having cold type of urticaria. In 37.87% patients, sourfood were found as major aggravating factor.
60.60% patients were practicing *Vishamashana*while 10.60% were having *Adhyashana*. And 33.33% were taking *Viruddhashana*. The dominancy of *Rasa* inthe diet was *Katu* *Rasa* (92.42%). 43.93% patients were havinghistory of *Diwaswapa* and 13.63% patients were having history of *Ratrijagrana.* 45.45% of patientswere of *Vata*-*Pitta Prakruti.*
*Vartidanshta Sansthana Sotha*and *Kandu* were found in allpatients*.* 89.39% and 84.84% patientswere having complaint of *KshnikotpatiVinasha* and *SotsangaSaraga Mandala* respectively. *Vidaha* and *Raktavarna Pidika* werefound in 80.30% and 75.75% patients respectively. *Toda* was found in36.36% patients. *Aruchi* was found in 92.42% patients. 72.72% patientswere having *Vibandha*. *Jvara* was found in 40.90% patients. 39.39%patients were having *Hrillasa. Raktalochanta* was found in 15.15%patients and In 4.54% patients, *Chardi* was found. Dermatographism signwas present in 56.06% of patients. UAS score: wheals: Maximum 65.15% patientswere having Mild (<20 wheals/24 h) Score, whereas 25.75% patients wereModerate (20-50 wheals/24 h) score, 9.09 % Patients were having Severe (> 50wheals/24 h) score. Pruritus: Maximum 69.69% patients were having Moderate,whereas 15.15% patients were Mild and severe score. Maximum 80.30 % patientswere having very large (11-20) DLQI Score whereas 18.18% patients havingmoderate (6-10) DLQI score. 1.51% patients were having small (2-5) DLQI Score.
**Effect of therapy:**
Statistically highly significant[<0.001] decrease was found in symptoms like *Vartidamshta SamsthnaShotha, Raktavarna Mandala, Vidaha, Kshanikotpati Vinasha,* Interval of attacksin all groups. In *Toda* , statistically significant result was found ingroup A and group C while statistically insignificant result was found in groupB. Among the 6 cardinal symptoms of *Sheetapitta,*group B and group C has shown better results in percentage relief of 4symptoms while group A has shown better result in only one cardinal symptoms.
All three groups have shownstatistically highly significant results in UAS score. Group C has shownmore percentage relief in wheals followed by group B and group A. Group B hasshown more percentage reliefin pruritus followed bygroup C and group A.
DLQI has shown more percentagerelief in group B followed by group A and group C.
Insignificant decrease was seen in AEC and S.IgE inall groups but percentage relief was more seen in group B i.e.11.01% and 58.38%respectively
**Effect of therapy in Before treatment and after followup time:**
In *Vartidanshta Sansthana Sotha,Vidaha* and in Interval of attacks, statistically highly significant[<0.001] result was seen in all three groups but percentage changes was morein Group B while in *Raktavarna Mandala,* statistically highly significant[<0.001] result was seen in both A and B groups and significant result wasseen in group C but percentage changes was more seen in group B. In Toda,significant result was seen in group A and group C and insignificant result wasseen in group B but percentage relief was more seen in group B and C. In allthree groups, highly significant[<0.001] result was seen in *KshanikotpattiVinasha* but percentage relief was more seen in group A. Highly significant[<0.001]result was seen in UAS score but percentage relief was more seen ingroup A and in group B in wheals and pruritus respectively.
**Effect of therapy in aftertreatment and after follow up time:**
Insignificant [>0.05] result wasseen in *Vartidanhta* *Sansthana* *Sotha**,Toda, Raktavarna Mandala, Vidaha* and Interval of attacksbut percentage relief was moreseen in group A in *Vartidanhta* *Sansthana* *Sotha.* Group Bwas better for percentage relief in *Raktavarna Mandala* and Interval ofattacks and Group C was better for percentage relief in *Toda* and*Vidaha.* In group A and B, Insignificant result was seen in *KshanikotpattiVinasha* and significant result was seen in group C but percentage reliefwas more seen in group A. In UAS score, Insignificant [>0.05]results was seen in all three groups. but percentage relief was more inGroup B in wheals and pruritus.
**Comparative effect of therapy ofall the groups**
Group C was insignificantly decrease in *VartidanshtaSansthana Sotha* (70.73%) and *Raktavarna Mandala* (88.89%) and highlysignificantly decrease in *Kshanikotpati Vinasha* (79.18%). Group B wasinsignificantly decrease in *Vidaha* (62.20%)and highlysignificantly decrease in interval of attacks (61.06%) while group A wasinsignificantly decrease in *Toda* *Adhikya* (77.92%).
UAS Score: Group C was highly significantly decreasein wheals (75.00%) while Group B was insignificantly decrease in pruritus(65.79%). In comparative effect of DLQI, group B was highly significanlydecrease i.e. 54.84%.
**Overall effect of therapy:**
Group B has shown better resultthan other groups. In group A 50.0% patients showed marked improvement, 45.0%patients showed moderate improvement, 5.0% patients showed mild improvement.None of the patients showed complete remission and unchanged. In Group B 40.0% showed moderate improvement, 60.0%Patients showed marked improvement. None of the patients showed completeremission, mild improvement and unchanged and In Group C 55.0% showed moderateimprovement, 45.0% Patients showed marked improvement. None of the patientsshowed complete remission, mild improvement and unchanged.
In clinical study it is noted that,there was no significant difference in effect of treatment among 3 groups i.e.even with standard control (cetirizine) on cardinal symptoms whichsuggests that both the treatment groups are equally effective as that ofstandard control (cetirizine) against management of these symptoms. significantlyincreased as that of increament in duration of interval in between attacks instandard control and group A. *Kshanikotpatti* (Duration of persistanaceof lesions) has been highly significantly reduced in standardcontrol(cetirizine) receiving group as that of other groups. There was highlysignificant reduction in area of wheals in standard control group C, as that ofgroups received HK (group A & B). In reduction of DLQI score, group B wasstatistically highly significantly different (exhibited best reduction) thanthat of 2 groups Thus it is concluded that, both the HK receiving group do havealmost similar effect on relief in cardinal symptoms of *Sheetapitta* asthat of standard control cetirizine.
**Thus, alternative hypothesisstating that ‘‘*Haridrakhanda* prepared with milk will be more beneficialin *Sheetapita* in comparison to *Haridrakhanda* prepared withoutmilk’ is accepted and rejecting null hypothesis.**
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- (1)Patients with all forms of Sheetapitta (Urticaria) with classical signs & symptoms of Sheetapitta (Urticaria).
- (2)Age- 18 to 60 years.
- (3)Gender- Both Males and females.
- (4)All types of Urticaria will be included (with chronicity of more than 8 weeks and frequency of wheals and flares not less than twice/week or 10 times/month) without any medicine or requiring medications for urticaria atleast twice weekly to remain asymptomatic.
- (1)Age <18yrs &>60yrs.
- (2)Pregnant women (3)Giant Urticaria, Angioedema, History of anaphylaxis (4)Uncontrolled Diabetes Mellitus (5)Any other serious systemic illness like AIDS, Malignancy etc (6)Patients who are not willing to get included in the study (7)Severe anemia (Hb<7gm/dl) (8)Widespread dermatological infections, Parasitic infections (9)Patients with conditions significantly exaggerating urticaria/itching e.g. severe Photosensitivity leading to photodermatitis, Albinism, extensive vitiligo, Severe extensive eczema.
- (10)Known cases of Hyperbilirubinemia, Hypothyroidism, Cases of alcoholism.
- (11)Drug induced urticaria, urticaria due to recent onset contact dermatitis.
- (12)Patients on drugs with possible interference with urticaria like penicillins, antiallergic drugs like antihistaminics, systemic steroids, mast cell stabilizers, Histamine 2 receptor blockers, adrenergics, decongestants, tranquilizers (tricyclic antidepressants), Salicylates, ACE inhibitors etc for other associated conditions and these conditions which may require above cited drugs as part of management.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effect of Haridrakhanda on Sheetapitta (Urticaria) improvement will be assese after 1 month
- Secondary Outcome Measures
Name Time Method Comparative efficacy of Haridrakhanda and Haridrakhanda without milk on Sheetapitta(Urticaria) 10 weeks
Trial Locations
- Locations (1)
PG Hospital IPGT and RA Jamnagar
🇮🇳Jamnagar, GUJARAT, India
PG Hospital IPGT and RA Jamnagar🇮🇳Jamnagar, GUJARAT, IndiaPriti RathavaPrincipal investigator8141989972pritir737@gmail.com